20200801 Florida Department of Health Updates New COVID-19 Cases, Announces One Hundred Seventy-Nine Deaths Related to COVID-19 – Florida Disaster

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8/1/2020

~474,621 positive cases in Florida residents and 5,407 positive cases in non-Florida residents~

The Florida Department of Health (DOH), in order to provide more comprehensive data, releases a report on COVID-19 cases in Florida once per day. The DOH COVID-19 dashboard is also providing updates once per day. The state also provides a report detailing surveillance data for every Florida county, which is available here.

In order to make the daily COVID-19 report easier to download and more accessible, the daily report will now separate case line data in a separate PDF. Both reports will continue to be updated daily. The case line data report is available here.

Test results for more than 100,500 individuals were reported to DOH as of midnight, on Friday, July 31. Today, as reported at 11 a.m., there are:

On July 31, 11.08 percent of new cases** tested positive.

There are a total of 480,028 Florida cases*** with 7,022 deaths related to COVID-19.

Since July 31, the death of one hundred seventy-four Florida residents who tested positive for COVID-19 have been reported in Bradford, Brevard, Broward, Charlotte, Citrus, Collier, Dade, Desoto, Duval, Escambia, Franklin, Gadsden, Gulf, Hernando, Highlands, Hillsborough, Indian River, Jackson, Lee, Manatee, Marion, Monroe, Okaloosa, Orange, Osceola, Palm Beach, Pinellas, Polk, Putnam, Santa Rosa, Seminole, St. Johns, St. Lucie, Sumter, Volusia and Wakulla counties.

Florida long-term care facility data:

The antibody COVID-19 test results report will be provided once a week and contains county, race and lab information on antibody COVID-19 tests conducted in Florida. The report for antibody tests conducted by private health care providers is available here and the report for antibody tests conducted at state-supported COVID-19 testing sites is available here.

More information can also be found here.

* Florida residents that are diagnosed with COVID-19 and isolated out of state are not reflected on the Florida map.

**This percentage is the number of people who test positive for the first time divided by all tests, excluding people who have previously tested positive.

***Total cases overview includes positive cases in Florida residents and non-Florida residents tested in Florida.

More Information on COVID-19

To find the most up-to-date information and guidance on COVID-19, please visit the Department of Healths dedicatedCOVID-19 webpage. For information and advisories from Centers for Disease Control and Prevention (CDC), please visit the CDC COVID-19 website, this website is also available in Spanish and Creole.For more information about current travel advisories issued by the U.S. Department of State, please visit the travel advisory website.

For any other questions related to COVID-19 in Florida, please contact the Departments dedicated COVID-19 Call Center by calling1-866-779-6121.The Call Center is available 24 hours per day.Inquiries may also beemailed toCOVID-19@flhealth.gov.

About the Florida Department of Health

The Florida Department of Health, nationally accredited by the Public Health Accreditation Board, works to protect, promote and improve the health of all people in Florida through integrated state, county and community efforts.

Follow us on Facebook, Instagram and Twitter at @HealthyFla. For more information please visit http://www.FloridaHealth.gov.

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20200801 Florida Department of Health Updates New COVID-19 Cases, Announces One Hundred Seventy-Nine Deaths Related to COVID-19 - Florida Disaster

Covid-19 Testing Is in Short Supply. Should You Still Get a Test? – The New York Times

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What is a conscientious person who already wears a mask and maintains social distance to do?

Yes, said R. Alta Charo, a professor of law and bioethics at the University of Wisconsin-Madison.

One of the most important things to keep in mind when discussing public health is the fact that this is fundamentally a community issue, not merely an individual health concern, she said. We are all in this together. What I do affects everyone around me, and what they do affects me.

If public health experts want people to be tested, they should comply, especially if the goal is to gather critical information about how many people are infected at a given point, Professor Charo said.

Epidemiologists can use the data to determine how fast the virus is spreading and which measures are working, she said.

Taking a test, like wearing a mask, shows a desire to be a part of the solution, said Dr. K. C. Rondello, an epidemiologist at Adelphi University in Garden City, N.Y.

The virus has been difficult to control in large part because many infected people without symptoms have unknowingly spread it, he said.

More testing will help identify these hidden cases, Dr. Rondello said.

But Candace L. Upton, a professor of philosophy at the University of Denver, said people should not feel duty bound to get a test. It can even be argued that it is morally wrong to go in for a test if you have no symptoms and are not at a high risk, she said.

Until there is no longer a shortage of test kits, it is morally unjustified to test patients for Covid-19 solely for the purpose of collecting data, Professor Upton said. Because of the deficit, labs shouldnt be offering them to people who are just curious.

The priority should remain testing only those with symptoms or compromised immune systems, and essential workers and older people, she said.

Professor Upton added that testing should be done selectively even in locations where tests are readily available and where results can be delivered quickly.

The whole system is unfair, she said. And so to take advantage of surpluses in certain places in the market is to add to the injustice to people who didnt have availability in the first place.

The national failure to coordinate testing efforts shouldnt cause people with no symptoms to feel conflicted about being tested for the coronavirus, said Dr. Andrew Diamond, chief medical officer at One Medical in San Francisco, a membership-based primary care practice with offices around the country.

If there is a way for you to get tested that does not clearly and directly impair someone who is a priority, then you should get tested for sure, he said.

Molly Wallace, 24, who grew up on Marthas Vineyard, was tested after she moved back to the island from Boston in March.

She was furloughed from her job as a medical assistant and began volunteering at a testing site, Test MV, at Marthas Vineyard Regional High School, where she went to school.

Updated July 27, 2020

Ms. Wallace said that she had never had coronavirus symptoms but that she had still felt obligated to be tested. I dont want to be the person to bring Covid here, she said.

All residents and visitors to the island are encouraged to be tested at Test MV, where volunteers distribute free kits of self-administered nasal swabs, said Ms. Wallace, who is now the sites outreach coordinator.

During her interview last week, Ms. Wallace said that people typically got their results within 72 hours, or more quickly if they test positive for the virus. At the time, Marthas Vineyard stood in stark contrast to states like New York and Arizona, where lines for tests have sometimes stretched around blocks and the turnaround time for results has been days, if not weeks.

On Friday, she said the turnaround time for tests was now around seven days, because of the shortage.

Wearing a mask should feel obligatory, Dr. Diamond said, but taking a test should not.

If tests were widely available and turnaround times for results were much faster, people would have a stronger sense of obligation to get tested, he said.

Under the current circumstance, I would say its much more important to continue to do what youre doing, Dr. Diamond said. That is, wear a mask, keep six feet away from people and stay home as much as possible, he said.

Dr. Diamond added, The behavior is really the thing thats going to make the biggest difference.

Remy Tumin contributed reporting.

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Covid-19 Testing Is in Short Supply. Should You Still Get a Test? - The New York Times

Whitmer on rising COVID-19 cases: ‘Weve got to tighten things up’ – The Detroit News

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Gov. Gretchen Whitmer toldCNN's "Cuomo Prime Time" on Friday night that she wastightening restrictions again in parts of Michigan after a rise in COVID-19 cases to "nip this in the bud."

She told host Chris Cuomo that Michigan had, about two months ago,been among the few in the United States in line to contain the virus but since then, some residents have been lax in efforts to control the spread"and weve seen our numbers climb."

"I'mtying to nip this in the budso we dont have to contemplate going back to a shutdown orback a phase in our re-engagement plan," she said.

MORE: Whitmer vetoes bill directing COVID-19 patients away from nursing homes

Wednesday, the governorreimposed limits in the Upper Peninsula and 17 counties in northern Michigan, capping indoor gatherings at 10 people and closing indoor bars where alcohol accounts for 70% of sales restrictions already in force in the southern part of the state.

Michigan confirmed eight coronavirus deaths Friday and 734 new cases ofCOVID-19. The seven-day average of new cases grew to 726 through Friday, compared with an average of 577 a day for the previous seven-day period.The state's overall case tally reached 81,621 and the death count hit 6,199, according to the Michigan Department of Health and Human Services.

State officials have recently cautioned about the rising cases in Michigan and urged residents to wear masks and practice social distancing so schools can reopen to in-person instruction in the fall.

"If want to have any shot ofgetting our kids safely back in school ... our actions today are going to dictate whether or not thats possible," Whitmer told Cuomo. "So thats why weve got totighten things up now."

When asked about the state's response in handling the pandemic, the governor said her administration is "letting the science and the facts dictate the decision making."

"When we see our numbers climb and we see the rate of positive cases climb,were doing more testing than ever. And thats a good thing," she said. "But we do see growth all across the state. And thats why its really important that we take action so we try to avoid this increase."

Whitmer also addressed the Clare County sheriff's Facebook post this week criticizing what he calledinconsistencies in herexecutive orders, and telling state officials to "stay in LANSING, and we will do what we will in FREE MICHIGAN!!"

"Its not popular with some, we know this," she said, but "thevast majority of people in this state are taking this seriously. Theyre doing the right thing."

Whitmer added: "I'm not going to bebullied into making decisions that I know jeopardize lives of the people that I serve. And so were going to stay tethered to the science. Were going to make decisions that are going to save peoples lives and hopefully keep this economy engaged. And it's on all of us. Every one one of us has a role to play. And if we drop our guard, then were going tojeopardizeall of the sacrifice that weve made to get us into this strong position."

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Whitmer on rising COVID-19 cases: 'Weve got to tighten things up' - The Detroit News

Trump heads to his own golf club as Covid-19 surges and jobless benefits expire – The Guardian

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Donald Trump prompted a familiar barrage of criticism on Saturday by visiting one of his own golf clubs as the country remains caught in numerous intensifying crises from the raging coronavirus epidemic to anti-racism protests to the failure to extend benefits to tens of millions of jobless Americans.

Trump arrived at his Virginia golf club in the morning, according to a report from the White House pool, after leaving Washington via motorcade and dressed in his usual golfing attire of a baseball cap and a polo shirt.

CNN, which tallies Trump trips to his golf clubs, reported that the visit was Trumps 283th trip to a golf course while in office and his 376th day at a Trump property.

In the 2016 campaign, and before, Trump often lambasted then president Barack Obama for his visits to the golf course and claimed that he would be too busy to play the sport if he was president. Since taking office, Trumps visits to golf courses have far outpaced Obamas.

Trumps latest visit comes as the death toll in the US from the coronavirus tops 153,000 with more than 4.5 million positive cases by far the largest totals in the world. It also happens as Washington fails to agree on an extension to a vital $600 dollar payment to jobless Americans who will now lose that benefit.

The visit triggered much online criticism, including from some anti-Trump Republicans.

Im glad hes playing golf. Id pay him to play golf for the rest of his Presidency. The country would be much safer and much better off if all he did was golf for the next 5-6 months, tweeted Joe Walsh, a former Republican congressman who ran a brief and unsuccessful bid to oust Trump as the partys nominee in the 2020 election.

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Trump heads to his own golf club as Covid-19 surges and jobless benefits expire - The Guardian

Indiana student tests positive for Covid-19 on first day of school – CNN

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The Hancock County Health Department notified Greenfield-Central Junior High School Thursday afternoon that one of their students, who had attended part of the school day, tested positive for Covid-19, Superintendent Harold Olin said in a letter.

Olin said the school enacted its "Positive COVID-19 Test Protocol" once school officials became aware of the positive result.

School officials immediately isolated the student within the school's clinic, and they examined the student's schedule, including transportation and extracurricular activities, to determine who had come in close contact.

As part of the district's return to in-person learning, "all areas of all schools" are already being disinfected professionally each evening, according to Olin's letter. But the superintendent noted that special attention would be given to areas and classrooms that the infected student had visited.

"We understand that this information will cause concern for some of you. It was very evident today that nearly all of our families and students were prepared to properly follow the safety protocols we have established," Olin said. "Adhering to these protocols is essential for maintaining a safe environment for all students and staff."

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Indiana student tests positive for Covid-19 on first day of school - CNN

MLB optimistic that Phillies’ last two COVID-19 tests were false positives – ESPN

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1:07 PM ET

Jeff PassanESPN

The Philadelphia Phillies are optimistic that their last two positive COVID-19 tests -- with a coach and clubhouse attendant -- were false positives, Major League Baseball announced Saturday.

The Phillies, who are a week separated from games against the Miami Marlins with no positive tests among players through Friday's testing, are permitted to access Citizens Bank Park for staggered workouts beginning Saturday.

While three staff members have since tested positive since playing the Marlins, MLB on Saturday said "it appears that two of those individuals' tests were false positives, and it is unclear if the third individual contracted COVID-19 from Marlins players and staff based on the timing of the positive test."

False positives would be good for the Phillies because it would take the incubation period of the team's most recent exposure back to last Sunday against the Marlins, who have had 21 positive tests within their organization since that game.

The Phillies have not played since Sunday "out of an abundance of caution," MLB said Saturday, with series against the New York Yankees and Toronto Blue Jays being postponed.

Major League Baseball said the Phillies are currently scheduled to resume play this week with a four-game series against the Yankees -- in New York on Monday and Tuesday and at home Wednesday and Thursday.

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MLB optimistic that Phillies' last two COVID-19 tests were false positives - ESPN

Group home residents are dying of COVID-19 at higher rates but an underfunded system sets them up for greater risk – AZCentral

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Among nearly 5,000 people with developmental disabilities living in state-licensed group homes in Arizona, 320 have tested positive and 21 have died.(Photo: Ingram Publishing, Getty Images/Ingram Publishing)

People with disabilities who live in state-licensed homes and facilitieshave diedof COVID-19 at more than twicethe rate of those who live with family or own their own homes, according to state data.

The virus has killed 21people with developmental disabilities living in state-licensed settings, bringingthe death rate to about 6.5%.

Among nearly 5,000 residents, 320 have tested positive.

Those settings include group homes,which are by far the most common,or situations where a person lives alone but relies on caregivers to help with daily tasks. They also include Adult Development Homes, where familieshostresidents in their houses, and intermediate care facilities, which are similar to nursing homes.

Experts say people living in these placesmay also get delayed treatment because staff mightnot notice their symptoms as early as family would. Or, experts say, this population might be more proneto severe cases because they tend to be older and have more medical issues than those wholive with family.

Stephanie Silvera, an epidemiologist and professor of public health at Montclair State University in New Jersey, suggested that theymight suffer tougher bouts of COVID-19 becauseliving withother sick residents exposes them to larger viral loads or because they're cared for by numerous employees who could bring the virus to work.

This is all speculation, however, because the state releases such little data on the matter.

Epidemiologists and advocates interviewed by The Republic said to betterunderstand how the disease is affecting this vulnerable population they'd want to know the number of people tested, the ages of people who fell ill or died and what group homes or facilities had experiencedoutbreaks.

Families have repeatedly asked for more information during town hall meetings with the division, only to be told that sharing such data would jeopardize people's right to privacy on health matters, saidJon Meyers, executive director of the Arc of Arizona.

The Arc of Arizona is anadvocacy group for people with disabilities. Meyerstoohas requested suchinformation so his organizationcan better support people in areas hardest hit by COVID-19. The state said no, he said.

Less than 1% or 308of the 39,000-plus state disability system members who live with family or own their home have tested positive, and 3% of them have died.

"What thismeans is if you live in a group home or an intermediate care facility or an adult development home,your risk is a lot higher," Meyers said."To me that would indicate that something is not being done to keep the virus out of the residential settings."

About 6%of people with developmentaldisabilities who live in state-licensed homes or facilities have tested positive for COVID-19. That is much higher than the overall population's infection rate in Arizona of 2%.

Some of the disparity can be explained by more testing of peoplein congregate living settings, as everyone in an intermediate care facility has been tested under a government mandate.

But those residents account for a small fraction of people who live in state-licensed facilities.

The Republic asked the Department of Economic Securityfor the number of residents who'd been tested. But the Division of Developmental Disabilities, which is part of that department and charged with overseeing services for roughly 44,000 people with developmental disabilities, does nottrack that number, said Brett Bezio, spokesperson for the department.

The Arizona Department of Health Services did not answer questions about testing statistics for that population.

Epidemiologists and advocates for people with disabilities, however, said it's likely that more testing among a subset of that population doesn't explain away the entire discrepancy.

"In this situation where you're not only finding a higher proportion of cases but a higher mortality rate, that leads me tothink that may not be due to differences in testing rates alone," Silvera said.

Congregate living settings such as group homes face unique challenges during a pandemic. Maintaining a distance isn't possible when staff have to help residents with daily tasks such as bathing. Alsoemployeescome and go.

Employees are the main source of resident outbreaks,said Gina Griffiths, director of programs at the Opportunity Tree. Ahandful of her group home residents have gotten COVID-19. She couldn't say how many employees have tested positive.

Her organization requires group home staff to take their temperatures twice during ashift, though she acknowledged the absence of a fever doesn't mean someone's in the clear. None of the residents who tested positive had fevers.

But taking temperatures is at least something. Anything to chip away at the "feeling of helplessness."

"The biggest thing that we have zero control over is what is our staff is doing when they're not at work," she said."I want so much to say 'you all need to stay home and order your groceries online.'"

But she can't. Sure, she can try: She started a contest forhundreds of direct caregivers to document the ways they're social distancing. Most haven't participated.

The reality is the state only provides enough funding for these employees who administer medication, bathe and feed people and manage aggressive behavior to earnminimum wage.

Some must work other jobs to supplement their income.

"We treat them like they're flipping burgers," Griffiths said.

And now, on top of all of that, these workers have to risk getting COVID-19 on the job. Fear among staff has risen with the growing cases in Arizona. Group home administrators industry-wide continueto lose employees, either from fear of going to work or because they've been exposed to the virus and can't work.

That puts residents at even greater risk because it can undermine one of the few tactics group home directors can use to try to reduce risk.

The Opportunity Tree tries to assignindividual group home employeestojust one home to try to prevent spread from site to site. But 12%of direct care workers were out last week because they were either sick or had been exposed to the virus.So some employees hadto stretch among different homes.

Whenresidents get sickthey isolate them, either by moving them to a different house or by sending their uninfectedroommates to a different one. Opportunity Tree is paying employees extra money to move in with COVID-19 positive residents but that's not supported by state funding.

It's also setting up computers and wireless internetat all group homes to help keep residents engagedand for leadership to beable tocheck in via video chatsto make sure staff are wearing masks as required.

That's another coststate funding won't cover.

Being able to test staff regularly would be a goodway to prevent spread among residents, but group homes don't have money for that either.

Griffiths said Arizona's most recent state study on disabilityservices showed that the systemis underfunded by $250 million to $400 million.

"It created a situation where there was no other way for us to be caught other than flat-footed," said Taylor Buttrey, the Opportunity Tree's manager of cultural programming and community engagement.

Emails between Coconino County health officials show just how difficult it can be to contain virus spread in group homes.

The emails were obtained through a public records request for theDocumenting COVID-19 project at the Brown Institute for Media Innovation.

Across 16 group homes run by the Hozhoni Foundationin Flagstaff, Coconino County health officials struggled to determine which group home residents had been exposed to COVID-19 in the aftermath of a death.

A May 18 email from the county's communicable disease investigator, Marette Gebhardt,to other health officials reported that all four residents at one grouphome had tested positive.

The health officials emailed over the next few days about mass testing.

"I believe we need to include staff in this testing as well as I think there are several who either have not received their results or who continue to work with positive clients and may not be using PPE appropriately etc," wrote Kim Musselman, director of special initiatives.

But later that day Gebhardt wrote that there would be "virtually no way to nail down all staff members and test them at exactly the right time."

She wrote that there were 100 caregivers, a lot of whom "live on or frequent the reservation,"who got tested there or outside the county so there wasn't a good way to find their test results.

She determinedthrough interviews and a search ofa statedatabase that employees with COVID-19 had worked at 12 of the 16 Hozhoni Foundation homes.

VIRTUALLY NO WAY TO PROTECT: against coronavirus outbreaks at disability group homes

"We just have to accept the fact that there will be ongoing transmission and continued community exposures and they need to switch their focus to taking proper precautions at work and preventing the spread at work," Gebhardt wrote.

She said she sent the group home leadership guidance on quarantine,mask efficacy and how to use PPE correctly.

Ultimately, the county was able to track down test results for 94 Hozhoni employees, 74 of which the county tested itself, Gebhardt said in an email to The Republic.

Gebhardtsaid testing staff at the right times was one of the biggest challenges. They were being exposed to COVID-19 both at work and outside of work which made it difficult to determine the exact day of exposure. And officials needed to know that to determine the length of quarantine and the best day for testing.

They also weren't aware of who already had been tested at sites not sponsored by the county and received negative results, as only positive resultsare required to be reported to the county, Gebhardt said.

To add to the challenge, test results are reported to the county where a patient lives. So Coconino County health officials were not made aware ofCOVID-19 positive employees if they lived outside the county, Gebhardt said.

Through working with other counties and state officials, they were able to track down most of those results, though.

The county also made sure all residents were tested.

Most residents who tested positive were asymptomatic, Gebhardt said.

"The biggest challenge was the inherent nature of this disease in that once someone was exposed, time was required to determine if they became infected and would potentially infect others," Gebhart said."Although Hozhoni implemented temperature checks, symptom questionnaires, and strict rules about not working while ill, it is still very difficult to contain the spread of COVID-19 once it is circulating within a group of people."

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Despite the virus' spread in group homes, the pandemic has not devastated themto the extent that advocates had expected.

Many group homes have been able to secure adequate personal protective equipment and cleaning supplies and many agencies shuttered day programs to avoid large groups of people from gathering.

Yet some smaller group homes are struggling to find enough PPE and cleaning supplies, Meyers said. And without regular testing, containing the spread of thevirus remains elusive.

Residents of nursing homes and intermediate care facilities all received testing under an executive order. The Arc of the United Statesis trying to get the Centers for Medicaid and Medicare Services to mandate testing in places like group homes.

Until then, the best administrators can do is require masks and extensive cleaning, restrict visitation and resident outings,take employee and resident temperatures and moveresidents into separate buildings whenthey showsymptoms.But by then, everyone else in the house would likely have caught the virus.

Robert St. John's Glendalegroup home roommates were spared when he got sick. He tested positive for COVID-19 after a bout of vomiting, said his sister, Kat Crawford.

Kat Crawford, Kelly Solomon and Robert St. John at a family celebration in 2018.(Photo: Kat Crawford)

The 34-year-old was diagnosed in March, and his group home moved him out immediately. He spent about three months in an empty building otherwise used for day program services.

He stayed in a classroom on a roll-away bed with a DVD-player and a shower and washer and dryer down the hall. Staff would drop off meals at his door, but not enter.

He watched the movie Twister 30 times.

St. John continued to test positive until the end of June. Crawford said occasionally other sick residents joined him in the building.

"The most stressful part was that I couldn't see him," she said. "I couldn't go over and check on him. I couldn't pick him up and hang out."

Reach Caitlin McGlade atcaitlin.mcglade@arizonarepublic.comor 602-444-0582. Follow her on Twitter@caitmcglade.

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Group home residents are dying of COVID-19 at higher rates but an underfunded system sets them up for greater risk - AZCentral

Florida couple busted for breaking COVID-19 quarantine insists they were just walking the dog – NBC News

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A Florida man who tested positive for COVID-19 and was busted along with his wife in Key West for allegedly violating a quarantine order insisted Friday he was just walking their dog and not trying to endanger anyone.

I didnt do anything, 24-year-old Freire Interian told The Associated Press. I was just walking my dog. Its not as if I left the house to go shopping.

Interian spoke out as the coronavirus continued to cut a deadly swath through Florida with the state breaking its daily death record for the fourth day in a down with 257 new fatalities, according to the latest NBC News tally.

The numbing new figure was reported on the heels of Florida notching 253 deaths on Thursday, 216 on Wednesday, and 186 more on Tuesday -- all of which were new daily highs in a pandemic has turned the state into a COVID-19 hot spot.

Meanwhile, Florida was being menaced by Hurricane Isaias and Gov. Ron DeSantis declared a state of emergency from Miami-Dade County all the way up the states Atlantic coastline a stretch that includes the counties with the biggest numbers of COVID-19 cases and deaths.

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As of Friday, Florida has reported 470,386 cases and 6,843 fatalities.

Nationwide, more than 4.5 million confirmed coronavirus cases have been reported along with 153,480 deaths, the NBC News figures show.

Interian was arrested along with his 27-year-old wife Yohana Anahi Gonzalez on Wednesday after neighbors videotaped them allegedly flouting the quarantine requirement, local officials have said.

They were each hit with misdemeanor charges of violating the state law that requires isolation or quarantine in a public health emergency and with violating emergency manages, conviction on which could send them both back to jail for up to 60 days.

Calling his arrest unfair, Interian said he was stunned when the Key West Police arrived at the house he shares with several other people.

They knocked on the door real loud, he said. I opened the door. They told me, Come on, and I asked them, Why? I was in shock.

Florida health officials, however, say Interian and Gonzalez learned they were infected on July 15 and were supposed to self-isolate for 14 days. But on July 20 they ventured out to a store and were caught doing so on video.

Interian and Gonzalez appear to be among the first people to be arrested in Florida for breaking quarantine. But they arent the first to run afoul of local quarantine regulations.

In Hawaii last month, 21 travelers were arrested for breaking the states mandatory 14-day quarantine, none of whom wound up testing positive. And in May, a 37-year-old Kentucky woman infected with COVID-19 was charged with wanton endangerment and criminal mischief after she was caught shopping for groceries while she should have been in isolation. It was the third time she had defied a quarantine order.

In other coronavirus-related developments:

Corky Siemaszko is a senior writer for NBC News Digital.

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Florida couple busted for breaking COVID-19 quarantine insists they were just walking the dog - NBC News

COVID-19 has arrived in Greater Minnesota – MinnPost

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The first confirmed case of COVID-19 in Minnesota was announced on March 6 three months after China told to the world that patients in Wuhan were sick with pneumonia of unknown cause.

That first case was an older Ramsey County resident who had disembarked from the COVID-stricken Grand Princess cruise ship before it was quarantined. By the next week, a Carver County resident who had been in Europe was confirmed to have the virus. So was an Anoka County resident who had been traveling for work.

All three cases were in the Twin Cities metro area, which was the first place to be hit hard by the virus. Soon, medium-sized cities started to see coronavirus activity, as well as some rural parts of the state, particularly those with food processing outbreaks. But even months after the virus was first detected in the state, some rural parts of the state still saw low numbers of officially confirmed cases of the virus.

Thats started to change in recent weeks. Now some Greater Minnesota counties that had previously seen little confirmed coronavirus activity have started to see upticks in cases. And as of last weekend, with a confirmed case in Lake of the Woods County, every county in Minnesota has at least one case of COVID-19.

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The novel coronavirus first appeared in the United States big cities, with a major outbreak in New York City back in April. In Minnesota, Hennepin and Ramsey counties were early centers of the outbreak.

Carrie Henning-Smith, an assistant professor in the University of Minnesotas School of Public Health said this may have given parts of rural America a false sense of security about the virus.

We know that COVID started in the U.S. as a distinctly urban phenomenon. We were first hearing about it in Seattle and New York and New Orleans,she said.

[Since] this took a long time to spread into some rural communities, I think that false sense of security may have become heightened. I think people looked around and said Im not sick, none of my neighbors have gotten sick lets move on and move back to life as normal, Henning-Smith said.

That may be changing in some areas now. Mahnomen County, in northern Minnesota, saw new cases per capita double between the second and third weeks of July, from 5.4 cases per 10,000 residents to 10.9 the same number of cases per capita as Hennepin County. In Koochiching County, on the Canadian border, new cases went from 10.3 per 10,000 people the week of the Fourth of July to 15 per 10,000 people the following week.

Source: Minnesota Department of Health

The county had seen some coronavirus activity prior to July, but really saw an increase from 3.3 new cases per 10,000 residents to 11.1 per 10,000 residents after the Fourth of July, according to Minnesota Department of Health data. In the most recent week of data, the number of new confirmed cases had slowed slightly, to 9.5 per 10,000 residents.

Our initial surge was a group of early 20-year-olds, Borgen said. Once the restrictions were released and folks were out at the bars, sporting events, recreation leagues, that kind of was the start of it for us.

Despite that cases had been present prior, hospitalizations had been few until recently, Borgen said. As of this week, four people were hospitalized with COVID-19 in Beltrami County.

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Up until now, I think people felt a little more like If I get sick, Im not going to get very sick, Borgen said.

Some of the hospitalizations weve had were of people who were fairly young and healthy and its a small enough community that people learn pretty quickly whos in the hospital, even if we do our best to prevent any of that from coming through formal channels, she said.

While some in the community may not have seen COVID-19 as a big problem locally before, people are realizing this maybe is something that could impact me and my loved ones, Borgen said.

Before South Central Minnesotas Watonwan County saw an outbreak of COVID-19 last month, Community Health Services Manager Julia Whitcomb noted some belief in the community that the virus wasnt a concern in the area.

We did see some of those beliefs thinking its not here, so why do I need a mask or why do I need to follow social distancing, she said.

Concern heightened when cases climbed, but Whitcomb says some resumed lax mask-wearing behavior before the statewide mask order took effect on Saturday.

While geography is one factor that separates some Greater Minnesota residents feelings about the virus from others in the state, its not the only factor. The pandemic and the states handling of it has also become highly politicized, with people on the right side of the political spectrum tending to downplay the seriousness of the virus and the utility of interventions like face masks, while those on the left assume the opposite position.

Ahead of a public discussion of a local mask mandate in Alexandria that was scheduled before Gov. Tim Walzs mask mandate and took place this week, city officials said 286 people contacted the council in favor of a citywide mask mandate, while 463 people told the council they opposed such requirements.

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Many who opposed the local mask mandate cited low case counts as rationale.

Its not necessary as we have very few cases in our city. I think it will just cause tension between people, wrote one who opposed a potential local mandate.

But politics also came into play.

One employee of a senior living center in town wrote in using their work email addresses opposing the mask mandate on political grounds: This pandemic has become more political than anything because it is forcing Americans to submit to rules/regulations that do not support the constitution that this great country was built on.

But as cases climb again nationally and public health officials initially often opposed to masks on the grounds of limited supplies of medical-grade ones come to a general consensus that they are effective in slowing the virus spread, that may be changing, too.

In a Harvard/Harris poll released this week, 79 percent of respondents said they supported a national mask mandate. A Fox poll of Minnesota residents released this month found the majority of respondents, 85 percent, felt strongly or somewhat favorable towards Minnesotans who wore face masks.

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Particularly in summer, Greater Minnesota plays host to tourists from all over the state and country. Some residents worry about what that means when it comes to the accuracy of case counts in their areas.

Jen Sumption lives in Longville, Minnesota, home to the Woman Chain of Lakes, a big summer tourist destination in Cass County, where there have been 54 confirmed cases of COVID-19, according to MDH data, up from 12 a month ago.

Last week, she submitted a question to local radio station KAXE during a discussion with Lt. Gov. Peggy Flanagan to express concern about how case numbers are reported.

In rural Minnesota weve experienced an increase in cases as we saw an increase in out of town visitors, also the fishing opener and the Fourth of July weekend, she wrote.

If she were a Twin Cities or out-of-state resident who had been traveling up to lake country for generations, she said shed look at the states case map and might be likely to think Oh wow, Cass County, pretty consistently low, low-risk. Lets do it, she told MinnPost.

But she says that map isnt an accurate reflection of everyone whos been in Cass County: if people travel north and get sick, whether theyre tested in Cass County or back home, their result is associated with their home county.

Sumption told MinnPost that in a trip to town this week, she watched cars go by on Highway 84, the main drag through the town of 150.

I would say there were at least 20 to 25 cars that passed by where I could see their tags, and half were out-of-state, she said.

Shes concerned these travelers might see the low numbers in Cass County and let their guard down when they visit, believing the virus isnt in the community.

I think its a very false sense of security because the numbers dont actually represent the number of people who are really infected here, she said.

Walker Orenstein contributed to this report.

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COVID-19 has arrived in Greater Minnesota - MinnPost

Africa in the news: New funding to fight COVID-19 in Africa, Somalias prime minister voted out, and political updates in Mali and Cte dIvoire -…

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New loans and grants announced across the continent in response to COVID-19

The International Monetary Fund (IMF) approved the largest emergency loan in its history on Monday, providing South Africa $4.3 billion as it deals with its most prolonged recession since World War II. The IMF said that the loan will address the severe economic impact of the Covid-19 shock as well as the challenge of debt sustainability following the pandemic. South Africa had previously received $1 billion from the New Development Bank and $300 million from the African Development Bank, and it hopes to secure up to $2 billion from the World Bank.

The IMF also approved a debt relief package worth up to $24.97 million for Burundiwith the goal of assisting the countrytoservice its debt over the next couple years. The IMF has now awarded $251.24 million in debt relief to 28 developing countriesfrom itsCatastrophe Containment and Relief Trustthis year, fundingthatit hopes will free up fiscal space for public health and economic recovery needs.

Also this week,the African Development Bank (AfDB) approved a series of pandemic-related relief packages. The bank will provide $97.7 million to Rwanda and $37.1 million to Djibouti, whilealsoawarding grants (from the banks $10 billion COVID-19 Response Facility) of $69 million to Ghana, $31.6 million to Uganda, and $53.3 million each to Gambia, Liberia, and Sierra Leone.In other AfDB news, also this week,an independent probe announced that it has cleared AfDB presidentAkinwumiAdesina of misconduct, verifying the findings of anAfDB-led inquiry earlier this year.

On Saturday, July 25,theparliament of Somalia voted to remove Prime Minister Hassan AliKhairefrom office. One-hundred and seventy of the 178 members backed the motion,which statedthatKhairefailed to pave the way for democratic electionsincludingby improving the unstable security situation posed by alShabaabmilitants.President Mohamed AbdullahiMohamed has namedDeputy Prime Minister Mahdi MohamedGuledto serve as interim prime minister,according to the presidentsoffice.

Somalia has for years set its sights on one person, one vote,or a universal suffrage election, but hasnot been able to implement the policyinthe countrysprevious two elections. In 2012, 135 clan elders chose theparliament, who in turn selectedthepresident. In 2016,14,025 clan-representatives held a run-offelectionin an airport hangar at AdenAddeInternational AirportinMogadishu. Lawmakers had aimed to hold the countrys first fully democratic election in a half century in 2021, but now that goal is shrouded in uncertainty.

Khaire, also a Norwegian citizen and former primary school teacher in Norway, was new to politics when he was named prime minister in 2017. As a memberof theHawiyeclan, he had served to balancepower with theDarod presidentin accordance with the 4.5 clan system, which traditionally has led to theDarodand Hawiye clans each taking one of the highest two positions of office.He had previously worked at the British firmSoma Oil and Gas, where he was thedirector of the Africa department.

In Mali, the Economic Community of West African States (ECOWAS)regional bloc continued to work towardbrokering a political agreementbetween President Ibrahim BoubacarKetaand a protestingopposition. Earlier this week, theECOWAS negotiators recommended a dealwherein the 31 candidates elected to the countrys parliament earlier this year under contested circumstances step down and that by-elections be held. The plan also includes an inquiry into the deaths of 11 anti-government protesters earlier this month. Although the protestors are calling forKetasresignation, ECOWAS instead called for the rapid formation of a unity government that includes the opposition. However, theopposition coalition leading the protests, known as M5-RFP or the June 5 Movement, has rejectedthe proposed ECOWAS plan.

In Cte dIvoire,the rulingRally ofHouphoutistsfor Democracy and Peace (RHDP)has nominated current President Alassane Ouattara to run for president again after the recent death of the partys former nominee and current prime minister,AmadouGon Coulibaly.Notably,earlier this year Ouattarahad alreadydeclined to run for a third terminfavorof a successor.As of this writing,Ouattara has not yet accepted the nomination, but plans to give a speech on August 6 during which experts believe he will announce his decision. Notably, theopposition claims that Ouattara is not eligibleto run again.

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Sparano Shares Progress Made in the Molecular Guided Management of Breast Cancer – OncLive

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The advent of gene expression assays has provided predictive insight into chemotherapy benefit that can be combined with prognostic information yielded by gene expression profiling to better target patients with breast cancer who are at higher clinical risk for the use of adjuvant chemotherapy, according to Joseph A. Sparano, MD.

The notion of precision medicine in breast cancer is not a new concept; it dates back to the 1970s when we began using ER and PR protein expression initially by ligand-binding assay and then by immunohistochemistry to identify patients who would benefit from adjuvant endocrine therapy, said Sparano, a professor of medicine and womens health at Albert Einstein College of Medicine, in a presentation during the 19th AnnualInternational Congress on the Future of Breast Cancer West, a virtual program by Physician Education Resource (PER).1

We then entered the second generation using gene amplification for HER2/neu via FISH testing to identify women who could benefit from adjuvant trastuzumab (Herceptin), an anti-HER2based therapy, added Sparano. Fifteen years into the third generation [we use] gene expression profiles to guide the use of adjuvant chemotherapy and endocrine therapy. We're currently pretty far into the fourth generation of assays in terms of mutational profiling, which can identify individuals who could benefit from targeted therapies.

In his presentation, Sparano, who is also an associate chairman in the Department of Oncology at Montefiore Medical Center, provided insight into advances made with gene expression profiles, the clinical utility of available assays, as well as future directions in this area.

Gene expression profiles first emerged in the breast cancer paradigm about 15 years ago based on unsupervised analyses, which indicated that breast cancer was a heterogenous disease, that there were distinct subtypes, and that prognosis could vary by subtype, according to Sparano. The unsupervised work resulted in the PAM50 assay (Prosigna), which can be used to identify the distinct breast cancer subtypes that exist.

The next generation of gene expression assays were based on supervised analyses, which evaluated genes associated with a better or worse prognosis. This research led to the development of various prognostic assays, which included the 21-Gene recurrence score assay (Oncotype DX) and the 70-Gene signature test (MammaPrint), among others.

One important point is that theres a lack of concordance in the prognostic classification provided by these assays, said Sparano.

Prospective Validation

The first trial to show that a gene expression assay could provide independent prognostic information was the B14 trial, which included archival samples from a total of 668 patients with estrogen receptor (ER)positive, node-negative breast cancer who had received treatment with tamoxifen for 5 years.

Fifty-one percent of patients fell into the low-risk group, which was defined as a recurrence score (RS) of less than 18, 22% of patients were in the intermediate-risk group (RS of 18-30), and 27% were in the high-risk group (RS of 31 or greater). The 10-year risk of distant recurrence was 7%, 14%, and 31%, respectively, for each of these groups.2

Further data revealed a statistically significant association for RS that was independent of age and tumor size, said Sparano. As such, RS was not a surrogate marker for these other factors; it provided independent prognostic information.

Results from another study, referred to as B20, went on to demonstrate prediction of benefit with these assays.3 A total of 651 patients with ER-positive, node-negative breast cancer were randomized to receive tamoxifen or tamoxifen plus chemotherapy. For the entire cohort you see approximately a 4% improvement in distant relapse-free survival for patients who received chemotherapy, noted Sparano. However, there was a very large benefit for patients who had a RS of 31 or higher; the absolute benefit was in the range of about 25% in the group with the highest RS, suggesting that one can identify, using this assay, a subpopulation of patients who are deriving all of the benefit from chemotherapy.

The prospective TAILORx trial included women with hormone receptorpositive, HER2-negative, and axillary node-negative breast cancer and they were randomized to treatment based on their RS.

Of the 10,273 women enrolled on the trial, 1629 who had a low RS of 0 to 10, were assigned to receive endocrine therapy alone (arm A). Women with a high RS of 26 to 100 were assigned to endocrine therapy plus chemotherapy (arm D). Those in the midrange who had a RS of 11 to 25 were randomized to receive either endocrine therapy plus chemotherapy in the standard arm (arm C), versus endocrine therapy alone in the experimental arm (arm B).

The study had a noninferiority design with invasive disease-free survival (iDFS) as the primary end point, and full information is expected after 835 iDFS events were reported.

We modified the mid-range group for several reasons. The TAILORx population excluded HER2-positive disease and we know that the 21-gene assay includes a HER2 module that drives the RS up and is associated with a higher score, but we know that most HER2-positive tumors have a higher RS, explained Sparano.5 As such, if you use the assay in a HER2-negative population, youll have a different RS distribution.

Additionally, the RS assay is used selectively in practice in situations where there is therapeutic equipoise, which is typically intermediate-grade tumors that are 1 cm to 2 cm; this results in more tumors having a score in the mid-range group, according to Sparano. The trial really needed to be designed to address that group, he said.

Moreover, the RS range was adjusted to preserve prediction in the highest-risk group and minimize the potential for undertreatment in the low-risk group, Sparano added.

Initial data from the low-risk group showed that at 5 years, the rate of freedom from recurrence of breast cancer at a distant site was 99.3% (95% CI, 98.7%-99.6%).4 This information was subsequently integrated into the American Joint Committee on Cancers Cancer Staging Manual, noted Sparano.

After a median of 7.5 years, results from the intent-to-treat population (arms B and C) were released and showed that the primary end point for iDFS was met (HR, 1.08; 95% CI, 0.94-1.24; P = .26), demonstrating noninferiority of endocrine therapy compared with the standard.6 Endocrine therapy alone was also found to be noninferior to chemoendocrine therapy with regard to freedom of recurrence of breast cancer at a distant site (HR, 1.10; 95% CI, 0.85-1.41; P = .48).

Investigators then examined whether any patients with a mid-range score were still deriving benefit from the chemotherapy. No benefit was observed with regard to increasing tumor size or grade, but statistically significant chemotherapy treatment interactions were observed between age, RS, and chemotherapy benefit. Patients who had a higher RS and a higher clinical risk within this younger group seemed to derive benefit, explained Sparano.

At 9 years, in those with a RS of 16-20, a 1.6% absolute benefit from chemotherapy was observed versus a 6.5% absolute benefit in those with RS ranging from 21 to 25, added Sparano.

An exploratory analysis looking at the impact of age and menopausal status on chemotherapy benefit in patients with a RS ranging from 16 to 25 showed that there was no benefit in older women with an increasing score. However, curves began to separate for younger women with a RS of less than 25, noted Sparano.

When examining absolute differences in 9-year distant recurrence rates by chemotherapy use in women 50 years or younger with RS of 16 to 25 stratified by RS and clinical risk, investigators noted that the estimated absolute benefit of chemotherapy in women with a RS of 16 to 20 who were not stratified by clinical risk was +1.6%. The estimated absolute chemotherapy benefit stratified by clinical risk was -0.2% in those with low clinical risk (n = 671) and a RS between 16 and 20 and +6.5% in those with high clinical risk (n = 215).7

When looking at the impact of age on chemotherapy benefit, investigators observed that women who were closer to menopause, aged 46 to 50 years, experienced the greatest benefit. Interestingly, younger women really had no benefit, suggesting that some of the effect that was seen with chemotherapy in these younger patients who had higher RS might have been due to a castration effect, explained Sparano.

At 9 years, a 3% distant recurrence with endocrine therapy alone was observed in patients with an RS of 0 to 10 (arm A). An overall 5% distant recurrence rate was reported in those with an RS between 11 and 25 (arms B and C). Between arms B and C, a less than 1% difference was observed for all end points. In those with a RS between 26 and 100 (Arm D), a 13% distant recurrence was observed, despite chemotherapy plus endocrine treatment.

MINDACT

The MINDACT trial included 6,693 patients who were assigned to a clinical risk or a genomic risk. Patients who had discordance in their clinical and genomic risks were randomized to receive either no chemotherapy or chemotherapy.8 The primary end point of the trial was distant metastasis-free survival at 5 years for those with high clinical risk and low genomic risk without chemotherapy.

No effect with chemotherapy was observed in older women, but there was a 5% benefit from chemotherapy in younger women, which is very similar to what we saw in TAILORx, said Sparano.

The phase 3 Plan B trial used the Oncotype DX Recurrence Score to define a genomically low-risk subset of patients with clinically high-risk pN0-1 early breast cancer for adjuvant treatment with endocrine therapy alone. A total of 3198 patients were enrolled on the trial and chemotherapy was omitted in 86.1% of eligible patients with a RS of 11 or less.

At a median follow-up of 5 years, DFS in the patients treated with endocrine therapy alone who had a RS of 11 of less was 94% versus 94% in those with an RS between 12 and 25 and 84% in those with an RS of greater than 25 (P < .001). In patients who received chemotherapy, the 5-year overall survival was 99% versus 97% versus 93%, respectively (P < .001).

This provided a limited amount of level 1 evidence supporting the use of the Oncotype assay in patients with low-volume disease, noted Sparano.

Future Directions

With all of the data yielded thus far, it is clear that gene expression assays provide prognostic information, that the 21-gene assay offers predictive information, and that the 70-gene assay provides prognostic information, according to Sparano.

Its important to remember that these assays are not interchangeable, and theres a lack of concordance in risk classification which needs to be considered when deciding which assay to use and what to do with the information yielded, concluded Sparano. Future plans involve integration of the clinical and gene expression profile information to recalibrate existing tools in an effort to provide more refined information regarding prognosis as well as an estimation of chemotherapy benefit.

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Sparano Shares Progress Made in the Molecular Guided Management of Breast Cancer - OncLive

Stress-sensing Molecule May Be Potential Therapeutic Target in ALS – ALS News Today

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A small molecule called microRNA-182-5p (miR1825p) is involved in the detection of cell stress and in the survival of motor neurons, the cells progressively lost in people inamyotrophic lateral sclerosis(ALS), a study in mice showed.

These findings shed light on the mechanisms behind ALS stress-associated nerve cell death and provide new potential therapeutic targets.

The study, MicroRNA1835p is stressinducible and protects neurons against cell death in amyotrophic lateral sclerosis, was published in the Journal of Cellular and Molecular Medicine.

MicroRNAs, or miRNAs, are small RNA molecules that target a specific genes messenger RNA (mRNA) the genetic blueprint derived from DNA and used as a template for protein production to prevent generation of that protein. A single miRNA can regulate several mRNAs.

Increasing evidence suggests that miRNAs dysregulation contributes to neurodegeneration in ALS patients, which may help toidentify new diagnostic biomarkers and develop new therapeutic approaches for ALS.

Notably, miRNAs were found to be involved in the detection and response to cell stressincluding oxidative stress, which promotes the toxic build-up of TDP-43 clumps, problems in mitochondria(the cells powerhouses), and nerve cell death in ALS.

Oxidative stress is an imbalance in the production of harmful molecules calledreactive oxygen speciesthat can lead to cell damage and death.

While problems in stress detection or response may contribute to nerve cell death in ALS, such underlying mechanisms remain largely unknown.

Researchers at West China Hospital of Sichuan University, in China, now have discovered that miR1825p, a microRNA known to be dysregulated in several cancers, is highly present in motor neurons nerve cells that control voluntary muscle movement and regulates stress-sensing mechanisms and cell death in a mouse model of ALS.

The team first found that while miR1825p was detected in several organs and tissues of healthy mice, its highest levels were present in the spinal cord, particularly in the region containing motor neurons.

The researchers then assessed whether miR1825p levels in the spinal cord were different between healthy mice and a mouse model of ALS.

Mice with ALS had significantly higher miR1825p levels in the pre-symptomatic and early symptomatic stages of the disease and significantly lower levels in the late stages, compared with healthy mice.

This drop in miR1825p levels in late ALS stages may be related to its characteristic, progressive loss of motor neurons, the researchers noted.

Database analyses identified a total of 399 potential genes targeted bymiR1825p, which were involved mainly in cell stress responses and cell death. Further tests in lab-grown mouse nerve cells, including motor neurons, showed that miR1825p was produced in response to several stress conditions associated with ALS.

These included oxidative stress, endoplasmic reticulum stress(a kind of stress response to defective protein production), andtumor necrosis factor (TNF) alpha, an inflammatory molecule.

Notably, blocking miR1825p in nerve cells under such stress conditions led to a drastic increase in cell death, while promoting higher-than-normal levels of miR1825p had a protective effect.

Further analysis revealed that miR1825p regulates nerve cell death by directly suppressing PDCD4 a critical protein in apoptosis, the natural process of programmed cell death and RIPK3 a wellknown regulator of necroptosis, a form of inflammatory cell death associated with motor neuron death in ALS.

These findings highlight that miR1835p is not only a stress sensor in motor neurons, but also an executive factor in neuron death programming, the researchers wrote, noting that it protects neurons against cell death under stress conditions.

Our study supplements current understanding of the mechanistic link between cell stress and death/survival, and provides novel targets for clinical interventions of ALS, the team wrote, adding that increasing the levels of miR1835p may potentially prevent motor neuron death in ALS.

Given that a previous study showed that white blood cells of Chinese ALS patients had significantly lower levels of miR1825p, compared with those of healthy people, miR1835p may have a systemic (body-wide) role in ALS, the researchers noted.

Marta Figueiredo holds a BSc in Biology and a MSc in Evolutionary and Developmental Biology from the University of Lisbon, Portugal. She is currently finishing her PhD in Biomedical Sciences at the University of Lisbon, where she focused her research on the role of several signalling pathways in thymus and parathyroid glands embryonic development.

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Ana holds a PhD in Immunology from the University of Lisbon and worked as a postdoctoral researcher at Instituto de Medicina Molecular (iMM) in Lisbon, Portugal. She graduated with a BSc in Genetics from the University of Newcastle and received a Masters in Biomolecular Archaeology from the University of Manchester, England. After leaving the lab to pursue a career in Science Communication, she served as the Director of Science Communication at iMM.

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Stress-sensing Molecule May Be Potential Therapeutic Target in ALS - ALS News Today

Electroceuticals/Bioelectric Medicine Market to Witness Tremendous Growth in Coming Years || Leading Players – BioElectronics Corporation, SetPoint…

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Electroceuticals/Bioelectric Medicine Market

For in-depth understanding of market and competitive landscape, this Electroceuticals/Bioelectric Medicine Market research report provides a lot of parameters and detailed data about Healthcare industry. The report offers persistent knowledge and information of revolutionizing market landscape, what already exists in the market, future trends or what the market expects, the competitive environment, and strategies to plan to outshine the competitors. Various market related parameters considered in this Electroceuticals/Bioelectric Medicine Market research report helps businesses for better decision making.

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Market Analysis:Global Electroceuticals/Bioelectric Medicine Market

The electroceuticals/bioelectric medicine market accounted to USD 17.26 Billion in 2016 growing at a CAGR of 8.1% during the forecast period of 2017 to 2024. The upcoming market report contains data for historic years 2015, the base year of calculation is 2016 and the forecast period is 2017 to 2024.

Major Market Competitors:Global Electroceuticals/Bioelectric Medicine Market

Some of the major players operating inelectroceuticals/bioelectric medicine marketareMedtronic, Abbott, Boston Scientific Corporation, Cochlear Ltd., Livanova PLC, Sonova, BIOTRONIK SE & Co. KG, Nevro Corp., SECOND SIGHT, electroCore LLC, Synapse electroceutical Ltd., BioElectronics Corporation, SetPoint Medical, Inc., Bright Medical Ltd, GlaxoSmithKline Plc, EnteroMedics Inc., Alphabet Inc., The Medicines Company, FRV ELECTROCEUTICALS and Valencia Technologies Corporationamong others.

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Market Definition:Global Electroceuticals/Bioelectric Medicine Market

Bioelectric medicine combines bioengineering, molecular medicine, and neuroscience to develop nerve-stimulating technologies for the parameter of biological processes during treatment of disease. Increasingincidences of chronic diseases such as cardiac and neurological disorders leads to the market growth. Thus, there is high demand for advanced bioelectric medicine for the treatment of these chronic disorders.

Major market drivers and restraints:

Market Segmentation:Global Electroceuticals/Bioelectric Medicine Market

The electroceuticals/bioelectric medicine market is segmented by product into implantable cardioverter defibrillators, cardiac pacemakers, spinal cord stimulators, cochlear implants, deep brain stimulators, transcutaneous electrical nerve stimulators, vagus nerve stimulators, sacral nerve stimulators and retinal implants.

By type of device the market is segmented into implantable electroceutical devices and non-invasive electroceutical devices.

By application the market is further segmented into cardiac pacemakers and implantable cardioverter defibrillators market, spinal cord stimulators market, cochlear implants market, deep brain stimulators market, transcutaneous electrical nerve stimulators market, vagus nerve stimulators market, sacral nerve stimulators market, retinal implants market and others.

Cardiac pacemakers and implantable cardioverter defibrillators marketis sub segmented by application into arrhythmia.Spinal cord stimulators (SCS) market is sub segmented by application into chronic pain, failed back syndrome (FBSS) and ischemia.Cochlear implants market is sub segmented by application into sensorineural hearing loss.Deep brain stimulators (DBS) market is sub segmented by application into Parkinsons disease, tremor, depression and other. Transcutaneous electrical nerve stimulators (TENS) market is sub segmented by application into treatment-resistant depression and other.Vagusnerve stimulators market is sub segmented by application into epilepsy and other.Sacral nerve stimulators (SNS) market is sub segmented by application into urinary incontinence and fecal incontinence.Retinalimplants market is sub segmented by application into retinitis pigmentosa.Other market is sub segmented by application into gastroparesis obesity, depression, migraine and spinal cord injury.

By end user the market is segmented into hospitals, clinics, research institutes and individual users.

On the basis of geography, electroceuticals/bioelectric medicine market report covers data points for 28 countries across multiple geographies such as North America & South America, Europe, Asia-Pacific, and Middle East & Africa. Some of the major countries covered in this report are U.S., Canada, Germany, France, U.K., Netherlands, Switzerland, Turkey, Russia, China, India, South Korea, Japan, Australia, Singapore, Saudi Arabia, South Africa, andBrazil among others. In 2017, North America is expected to dominate the market.

Competitive Analysis:Global Electroceuticals/Bioelectric Medicine Market

The electroceuticals/bioelectric medicine market is highly fragmented and is based on new product launches and clinical results of products. Hence the major players have used various strategies such as new product launches, clinical trials, market initiatives, high expense on research and development, agreements, joint ventures, partnerships, acquisitions, and others to increase their footprints in this market. The report includes market shares of electroceuticals/bioelectric medicine market for global, Europe, North America, Asia Pacific and South America.

Research Methodology:Global Electroceuticals/Bioelectric Medicine Market

Data collection and base year analysis is done using data collection modules with large sample sizes. The market data is analyzed and forecasted using market statistical and coherent models. Also market share analysis and key trend analysis are the major success factors in the market report. To know more pleaseRequest an analyst callor drop down your enquiry.

Demand Side Primary Contributors: Doctors, Surgeons, Medical Consultants, Nurses, Hospital Buyers, Group Purchasing Organizations, Associations, Insurers, Medical Payers, Healthcare Authorities, Universities, Technological Writers, Scientists, Promoters, and Investors among others.

Supply Side Primary Contributors: Product Managers, Marketing Managers, C-Level Executives, Distributors, Market Intelligence, and Regulatory Affairs Managers among others.

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Electroceuticals/Bioelectric Medicine Market to Witness Tremendous Growth in Coming Years || Leading Players - BioElectronics Corporation, SetPoint...

Digong forgot to mention the cure for Covid-19 The Manila Times – The Manila Times

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ONE of the highlights in President Rodrigo Digong Dutertes fifth State of the Nation Address (SONA) was his proposal to Congress to revive the death penalty through lethal injection.

The death penalty law was passed during the term of President Fidel Ramos, but was scrapped by President Gloria Macapagal Arroyo, who gave in to pressure from the Catholic Church.

The death penalty could decrease the commission of heinous crimes.

Digong said drug offenses would be covered by his proposed death penalty.

But how about rape with homicide, rape of a minor, murder, robbery with homicide and large-scale estafa?

How about law enforcers who commit grave offenses using their badges as a shield? Among the serious crimes by law enforcers is planting evidence on innocent citizens.

How about government officials who coddle big-time criminals?

The above-cited offenses should have been included by Digong as punishable by lethal injection.

If Congress considers the Presidents proposal to restore the death penalty, it should include the other heinous crimes mentioned above.

* * *

Congress should not listen to bleeding hearts like Amnesty International since they refuse to see the real crime situation in the Philippines.

Bleeding hearts were not able to stop the death penalty in many countries, including some states in the United States.

Why should they stop our country from restoring the death penalty?

* * *

I was expecting the President to announce the discovery by Filipino doctors of a cure for seriously ill coronavirus disease 2019 (Covid-19) patients in the SONA.

The citizenry, cowering in fear of the dreaded illness, would have appreciated the Presidents speech more if he had included the medical breakthrough.

The medical breakthrough was announced by Palace spokesman Harry Roque Jr. in a virtual press conference in Malacaang several days before the SONA.

However, the story was buried in the inside pages of major newspapers, a treatment it did not deserve.

The discovery of the cure for Covid-19 was made by scientists at The Medical City hospital through its Institute of Molecular Medicine stem cell program.

Stem cells taken from the blood of preserved umbilical cords worked their magic on six patients about to be intubated through intravenous injections.

I wrote about the medical breakthrough in my column last Tuesday, July 28.

For those who missed that column, you may want to read it at the Manilatimes.net.

* * *

A big supply of umbilical cords would bring down the cost of the stem cell therapy for Covid-19.

Tens of thousands of women give birth in the country and the umbilical cords of the newborns are thrown away.

The possible sources of umbilical cords are government hospitals and paanakan (maternity) centers.

The Philippines is a big manufacturer of babies.

Proof is that for a small country, our population has ballooned to 110 million.

To digress, I was a medical representative (detailman) in 1973 and one of the hospitals in Metro Manila that I was assigned to cover was the Fabella Memorial Hospital, a maternity hospital, in Sta. Cruz, Manila.

As I was fixing the promotional medicines I would give to some doctors at Fabella, I heard the screams of pain by a woman about to give birth at the delivery room.

Armando, Armando! P****g i*a mo! the woman was shouting, apparently referring to her husband.

I heard the nurse or midwife tell the woman, Tumigil ka nga diyan! Huwag mong sisihin ang asawa mo. Taun-taon nandito ka (Shut up! Dont blame your husband. Youre here every year).

See what I mean by the country being a manufacturing center of babies?

* * *

Another highlight of the Presidents SONA was his plan to establish the Coconut Farmers Trust Fund.

That part of Digongs speech was near to my heart as I come from Davao Oriental, a province where the main livelihood of the people is harvesting coconuts and turning them into copra.

Coconut farmers are the poorest in the country.

It was not so before, say, in the 1960s, when the price of copra was very high and coconut farmers in my hometown Manay could send their children to very good schools in Davao City and elsewhere.

But the price of copra in the world market is now very low and Filipino coconut farmers have become impoverished as a result.

However, the dying coconut industry might soon come to life again and the farmers could be rich once more.

An American friend of mine, Matt Grecsec, has invented a machine that converts coconut husk into hardwood for construction materials.

Grecsec, whos from Florida and married to a Filipina, has been coming to the Philippines looking for a place to set up his plant to make hardwood out of coconut husk.

Coconut husk is thrown away by farmers who make copra.

Grecsec has been meeting with Agriculture Secretary William Dar who has expressed enthusiasm for his project.

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Digong forgot to mention the cure for Covid-19 The Manila Times - The Manila Times

Coronavirus testing hits a wall: Where do we go from here? – MedTech Dive

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This story is part of a MedTech Dive series examining the impact of the COVID-19 pandemic on the medtech industry, published six months after the U.S. declared a public health emergency. You can find the other stories here.

When the U.S. declared a public health emergency on the final day of January in response to the coronavirus pandemic, it was clear the nation lacked the diagnostic capabilities to combat the rapidly spreading infection.

Six months later, COVID-19 cases are surging in the South and West. But despite new tests coming online from companies such as Abbott, BD, Roche and Thermo Fisher and a capacity ramp-up by commercial labs like LabCorp and Quest, the nation is still only able to muster 4.5 million tests per week.

Thats a far cry from the 30 million tests weekly needed within the next three months to safely reopen communities and state economies, and keep them open, according to the Rockefeller Foundation, which this month proposed a National COVID-19 Testing & Tracing Action Planto address the shortfall.

Echoing many other public health experts, the plans authors warn the U.S. is losing its battle against COVID-19 and that testing is the only way to avert further devastation until a vaccine or effective therapeutics are widely available.

The Rockefeller authors contend that within the next three months to contain the pandemic, what's required is access to diagnostic testing for Americans with symptoms at least 5 million tests per week with turnaround times of less than 48 hours as well as 25 million fast, inexpensive screening tests for asymptomatic people.

The national focus should not just be on bringing more COVID-19 diagnostic tests to the market, but significantly boosting onsite and home testing of people not showing symptoms,the foundation contends.

Abbott Labs, whose point-of-care ID Now platform was one of the first molecular tests to get an FDA emergency use OK,is also betting that large scale rapid testing is the next chapter of the pandemic response.

With the phased easing of shelter-in-place restrictions, were entering a new phase where continued testing of symptomatic patients will start to overlap with broader surveillance testing of asymptomatic patients in order to better track, understand and contain the spread of the virus until we have broad vaccine availability, Abbott CEO Robert Ford told investors on a July 16 second-quarter earnings call.

While the FDA has cleared more than 150 molecular tests, only two antigen tests, sold by BD and Quidel, have emergency use authorization.Abbott is now working on its own antigen test.

Unlike polymerase chain reaction tests, which detect viral genetic material, antigen testing is designed to determine if a sample contains proteins found on the surface of the coronavirus, enabling delivery of results in minutes rather than days.

Some public health experts are advocating a broad push using the antigen tests, especially as LabCorpand Quest struggle to keep up with increased demand for molecular diagnostics as U.S. coronavirus cases rise.

Whereas molecular tests are typically highly accurate and usually do not need to be repeated, FDA has recommended that negative results from antigen tests should be confirmed with a molecular test. In particular, the agency has warned that antigen tests are not able to definitively rule out active COVID-19 infection.

"Thats why when the FDA approved those assays, they approved it under the remark that if its negative you have to reconfirm it with a PCR assay. And obviously most are negative, so you have to do a lot of PCR assays following that,"Roche Diagnostics CEO Thomas Schinecker told investors on a Thursday earnings call.

However, Mara Aspinall, a biomedical diagnostics professor at Arizona State Universitys College of Health Solutions, makes the case that the U.S. cannot break the chain of transmission if the coronavirus outpaces public health efforts.

Whats needed is a paradigm shift from exquisitely accurate-but-slow tests to fast-and-good enough to quarantine," she said.Slow and accurate works for clinical management, but this virus is a sprinter not a marathoner.We need fast and frequent tests just to keep up."

That approach has been endorsed by top U.S. health officials, including National Institutes of Health Director Francis Collins and federal testing czar Brett Giroir.

Earlier this month, FDA granted emergency use authorization to BDs rapid, point-of-care coronavirus antigen test, making it only the second such diagnostic to receive a nod from the regulatory agency.

A Quidel product, which claimed the antigen category's first EUAin May, delivers results in 15 minutes.BD's test, which runs on the company's widely used Veritor Plus System, also delivers results in 15 minutes.

What appears to set Quidel's antigen-based diagnostic apart from BD's is its accuracy. Quidel on July 17 sharednew data showing its COVID-19 antigen test has 96.7%sensitivity which is comparable to the sensitivity rates of PCR tests, according to the company.

"Lower sensitivity had been an argument we have heard over and over about why antigen testing was not going to be used and this should help put that to bed," William Blair analysts wrote in a July 20 note to investors.

The analysts contend Quidel's latest data on its antigen test puts it "on par with many of the molecular tests on the market" as well as "above the performance of the other antigen test on the market from BD."

By comparison, BD's antigen test has 84% sensitivity. Asked if BD is looking to update its clinical performance data, a spokesperson told MedTech Dive they are not aware of any plans to do so.

As for Abbott,CEO Ford declined during the July 16 earnings call to provide specifics in terms of timing and when the diagnostic might be available. He did say antigen tests offer an interesting value proposition compared to molecular testing.Ford emphasized that Abbotts goal is to produce a reliable antigen test thats easy to use and, equally important, is affordable.

I think thats the critical aspect here. If we want to get to more mass screening, more mass volume, these tests need to be more affordable, and one of the ways you do that is you remove the restriction on the [lab-based] instrument, or requiring an instrument, he told investors.

When it comes to diagnostic testing, easy, fast, and cheap is also what the Rockefeller Foundation is advocating to bring tests to the U.S. market at a national scale needed to effectively respond to the pandemic. The organization envisions point-of-careantigen tests costing $5 to $10 per test, with same-day test results for schools and workplaces, and even faster turnaround times for mobile testing in communities.

Today the country conducts almost zero such [screening] tests, and we need at least 25 million per week for schools, health facilities, and essential workers to function safely, wrote Rajiv Shah, president of the Rockefeller Foundation, in the organizations proposed national testing plan.

The U.S. will need at least another $75 billion in federal funding for testing to reach the plans goal of 30 million tests per week by October, including at least 25 million fast, inexpensive antigen tests for asymptomatic Americans, according to the Rockefeller Foundation.

The call for more money for testing comes as a debate continues on Capitol Hill over what the next coronavirus relief bill should appropriate.The HEROES Act passed by House Democrats in May providesan additional $75 billion for testing but Senate Republicans are likely to come up with their own legislation with less funding.

Senate Republicans are considering much lower figures for testing as President Donald Trump has resisted more testing on a false claim that it leads to more cases.

The Rockefeller Foundation also wants the administration to invoke the Defense Production Act, or similar federal program, to jumpstart producing and distributing mass quantities of fast, low-cost antigen tests. The administration reluctantly used the Korean War-era law earlier in the pandemic to force industry's hand in producing ventilators.

Fueled by soaring demand for molecular diagnostic testing across the country,particularly in the South, Southwest and West, current test processing delays experienced by the two largest commercial labs are hamstringing Americas COVID-19 response.

Quest reportedJuly 20 that non-priority patients face average wait times for their test results of seven or more days, while "priority 1" patients, or those considered critical, are now having to wait an average of more than two days for results. A company spokesperson told MedTech Dive the company is "planning to issue updated numbers" on Monday afternoon."Otherwise, the July numbers are the most up to date," she said.

By comparison, LabCorp reported Sunday its average wait time for results was two to three days from specimen pickup, down from three to five days last week, and that turnaround times are "faster" for hospitalized patients.

Nonetheless, slower than 48-hour turnaround times for test results are making contact tracing ineffective. In fact, a studypublished on July 16 in The Lancet found that test results need to be delivered within a day of a person developing symptoms for contact tracing to be effective in reducing transmission of the coronavirus.

As LabCorp and Quest are having a hard time meeting hotspot-driven demand in a timely fashion,the Trump administration is hoping rapid point-of-care tests from Abbott, BD and Quidel can alleviate the pressure.

Giroir, lead for federal COVID-19 testing efforts, has touted the ability of antigen-based tests from BD and Quidel, as well as Abbott's ID Now molecular test, to be performed outside of lab settings in minutes rather than days.

The testing czar acknowledged Sunday that test results are taking too long. "The delays that most people talk about are at the large commercial labs that perform about half the testing in the country,"Giroir said on CNNs State of the Union, while estimating that the average turnaround is about 4.27 days."I would be happy with point-of-care testing everywhere. We are not there yet,"he added.

NIH director Collins has echoed those sentiments, commenting that wait times for test results are "too long" currently and rapid antigen-based diagnostics could be the answer.

Writing in a New England Journal of Medicine article published Wednesday, Collins and his co-authors noted that while PCR tests are highly sensitive they require a large amount of lab space, complex equipment, regulatory approvals for lab operations, as well as skilled technicians to run them.In addition, they said with this type of testing there is the need to transport specimens to a central lab that leads to further delays.

"For this reason, low-complexity molecular diagnostic point-of-care tests with rapid turnaround have substantial practical advantages," wrote Collins and others, who pointed out that antigen testing can provide quick results "similar to the way pregnancy tests operate." They noted that a number of manufacturers are currently developing them.

A Quest spokesperson told MedTech Dive that "there remains value in molecular diagnostic testing." At the same time, they said the company is "exploring the option to launch its own antigen test" but declined to disclose any additional details. LabCorp currently has no plans for antigen testing, according to a company spokesperson.

Quest's future plans for an antigen test aside, the company is taking other approaches to molecular testing in an attempt to maximize capacity.On July 18 it announced its PCR test, which first got emergency use authorization by FDA in March, was granted an agency EUA for sample pooling, a method meant to screen more people using fewer testing resources.

LabCorp announcedSaturday that it also received an EUA from FDA authorizing diagnostic testing of groups of individuals for active COVID-19 infections using pooled testing.

Sample pooling, in the case of Quest's molecular test, allows specimens collected from four individuals to be tested in a pool or batch using one test, rather than running each in its own test. LabCorp's pooled testing method involves testing up to five samples at once.

Quest acknowledges the inherent limitation of sample pooling:it's only an efficient way to evaluate patients in regions or populations with low rates of disease. Quest Chief Medical Officer Jay Wohlgemuth said in a statement that while sample pooling will help expand testing capacity it is not a "magic bullet" and "testing times will continue to be strained as long as soaring COVID-19 test demand outpaces capacity."

While LabCorp believes pooled testing can increase its overall testing capacity, the company concedes that specimens with low viral loads may not be detected in sample pools due to decreased sensitivity and that the method may be used for populations at low risk, when testing demand exceeds capacity, or when reagents are in short supply.

However, the Rockefeller Foundation argues that despite testing advancements such as sample pooling,the commercial labs cannot come close to fulfilling the nations screening test needs.

Lab tests arent convenient, simple, or inexpensive enough to use at the scale needed, the report says,calling for a ramp-up in antigen testing in schools, offices and beyond.

The Rockefeller Foundation also believes it is critical for the U.S. to look beyond commercial laboratories such as LabCorp and Quest that are overwhelmed and tap the testing resources of other underutilized labs, recruiting academic and other labs.

However, time is of the essence, according to Shah."We will soon enter a new cold and flu season with potentially 100 million cases of flu-like symptoms that stand to overwhelm our current testing capacity."

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Coronavirus testing hits a wall: Where do we go from here? - MedTech Dive

Study Suggests New Approach to Improve Radiation Therapy Resistance in Glioblastoma – Michigan Medicine

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The group found that the cell lines that were more resistant to radiation treatment also had higher levels of purines biological compounds that are known as the building blocks of DNA and RNA, and that can also activate signaling pathways.

This was very exciting because lots of different genetic mutations that occur in glioblastoma lead to this purine pathway being activated, Wahl says.

This suggested that they might be able to target the downstream effect of multiple genetic mutations.

We hypothesized that targeting this metabolic activity might work across tumor cells with different types of mutations instead of just whatever fraction of cells has that one particular genetic aberration you might go after with a mutation-targeting therapy.

Once the researchers discovered the correlation between high levels of purines and radiation resistance, they set out to demonstrate whether the metabolic changes actually caused the radiation to be less effective.

We gave cells more purines. It made them more resistant, Wahl says. We took away purines. It made them more sensitive to radiation. And we found it was doing this by affecting the cells ability to repair radiation-induced DNA damage.

To better understand whether targeting purine metabolism might help overcome resistance to radiation therapy in patients, the team used mouse models of glioblastoma with tumors grown from human patients cells.

They gave the mice a drug called mycophenolate mofetil, or MMF, which blocks purine biosynthesis and which has been approved for the treatment of organ transplant rejection since 2000.

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Tumor growth was moderately slowed down in mice who received radiation therapy alone or MMF alone, but almost totally halted in the mice who received both, Wahl explains. The benefits of MMF were similar whether animal tumors were grown in the brains of the mice or elsewhere in their bodies, demonstrating the drugs ability to effectively penetrate the blood-brain barrier which is critical for treating brain cancer patients.

Since the FDA has already found the drug to be safe enough to use in patients for one purpose, it makes it easier to set up a clinical trial aimed at a second disease, he says.

Ultimately, Wahl adds, the research was made possible by the collaborative, multidisciplinary environment at U-M where clinicians and researchers with expertise in glioblastoma can team up with others who specialize in cancer metabolism, data modeling and launching new clinical trials.

None of this happens without all these different teams sharing knowledge, models, methods and enthusiasm for making a difference in the lives of patients, he says.

Additional authors include Weihua Zhou, Andrew J. Scott, Kari Wilder-Romans,Joseph J. Dresser, Christian K. Werner, Hanshi Sun, Drew Pratt, Peter Sajjakulnukit, Shuang G. Zhao, Mary Davis, Meredith A. Morgan, Alnawaz Rehemtualla, Barbara S. Nelson, Christopher J. Halbrook, Li Zhang, Angela K. Walker, Maureen Kachman, Jianping Xiong, Maria G. Castro, Pedro Lowenstein, Sriram Chandrasekaran, Theodore S. Lawrence and Costas A. Lyssiotis of U-M; Yangyang Yao of U-M and First Affiliated Hospital of Nanchang University, China; Francesco Gatto of Chalmers University of Technology, Gteborg, Sweden; and Jann N. Sarkaria of the Mayo Clinic.

The research was supported by grants from the American Cancer Society, the Forbes Institute for Cancer Discovery, the National Cancer Institute (K08CA234416), the Jones Family Foundation Fund within the Chad Carr Pediatric Brain Tumor Center and U-M Taubman Emerging Scholars Program, as well as grants from the National Institutes of Health, the Michigan Institute for Clinical & Health Research, Rogel Cancer Center, an AACR NextGen Grant for Transformative Cancer Research (17-747 20-01-LYSS) and an American Cancer Society Research Scholar Grant (RSG-18-186-01).

Paper cited: Purine metabolism regulates DNA repair and therapy resistance in glioblastoma, Nature Communications. DOI: 10.1038/s41467-020-17512-x

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Study Suggests New Approach to Improve Radiation Therapy Resistance in Glioblastoma - Michigan Medicine

Atsena Therapeutics acquires exclusive rights to Gene Therapy for GUCY2D-associated Leber Congenital Amaurosis – BioSpace

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DURHAM, N.C., July 29, 2020 (GLOBE NEWSWIRE) -- Atsena Therapeutics, a clinical-stage gene therapy company focused on bringing the life-changing power of genetic medicine to reverse or prevent blindness, today announced that it has acquired exclusive rights to a gene therapy targeting GUCY2D-associated Leber congenital amaurosis (LCA1), a genetic eye disease that affects the retina and is a leading cause of blindness in children, from Sanofi, which originally licensed it from the University of Florida. The therapy was created in the laboratory of Atsena Founder and Chief Scientific Officer Shannon Boye, Ph.D., and Founder and Chief Technology Officer Sanford Boye, M.Sc., at the University of Florida.

We are thrilled that our gene therapy for LCA1 is coming home to Atsena and that we will have the opportunity to further its development, said Shannon Boye. Atsena was founded to advance treatments for inherited retinal diseases and believes in centering patients perspectives and needs in all we do. We are honored to continue to work with LCA1 patients and their families as we strive to treat this debilitating disease.

LCA is the most common cause of blindness in children, impacting two to three per 100,000. LCA1 is caused by mutations in the GUCY2D gene and results in early and severe vision impairment or blindness. GUCY2D-LCA1 is one of the most common forms of LCA, affecting roughly 20 percent of patients who live with this inherited retinal disease.

Atsena has an ongoing Phase I/II clinical trial evaluating this gene therapy in LCA1 patients. The second cohort in the trial is expected to be dosed in the fall of 2020.

Atsenas gene therapy has the potential to be a major advance in treating blindness in both children and adults affected by this inherited retinal disease, said Benjamin Yerxa, Ph.D., Chief Executive Officer of the Foundation Fighting Blindness and Atsena board director. The foundation was instrumental in supporting proof of concept studies in the founders labs over the last 15 years. Now, via investment in Atsena through our Retinal Degeneration (RD) Fund, we are excited to support this potential breakthrough treatment for LCA1.

Atsena closed a Series 1 funding of $8.15 million in April 2020, led by founding investors Hatteras Venture Partners and the Foundation Fighting Blindness RD Fund with participation by Osage University Partners, PBM Capital and the University of Florida. Patrick Ritschel, M.B.A., co-founder and former President of gene therapy company StrideBio, serves as Atsenas Chief Executive Officer.

Atsena is pleased to have the support of an enthusiastic investor base that shares our dedication to bringing the life-changing power of genetic medicine to patients living with LCA1 and other forms of blindness, said Ritschel. We look forward to working closely with our investors and patients as we continue to grow, and expect to announce additional milestones later this year.

About Atsena Therapeutics

Atsena Therapeutics is a clinical-stage gene therapy company, focused on bringing the life-changing power of genetic medicine to reverse or prevent blindness. The company has an ongoing Phase I/II clinical trial evaluating a potential therapy for one of the most common causes of blindness in children. Its additional pipeline of leading preclinical assets is powered by an adeno-associated virus (AAV) technology platform tailored to overcome the hurdles presented by inherited retinal disease, and its approach is guided by the specific needs of each patient condition. Founded by pioneers in ocular gene therapy, Atsena has a licensing, research and manufacturing collaboration with the University of Florida and is headquartered in North Carolinas Research Triangle, an environment rich in gene therapy expertise. For more information, please visit atsenatx.com.

Media Contact:Tony Plohoros6 Degrees(908) 591-2839tplohoros@6degreespr.com

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Atsena Therapeutics acquires exclusive rights to Gene Therapy for GUCY2D-associated Leber Congenital Amaurosis - BioSpace

Our Genes May Explain Severity of COVID-19 and Other Infections – Quanta Magazine

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Why was a marathon runner in his 40s stricken with a case of COVID-19 so severe it landed him in the intensive care unit? Why did a healthy 12-year-old boy lose his life to a disease that mostly harms older people? One of the most terrifying aspects of the pandemic is that the severity of the disease seems so cruelly and arbitrarily variable.

Although the SARS-CoV-2 virus is most often fatal in patients who are elderly or have chronic medical conditions such as diabetes, heart disease or high blood pressure, exceptions that bring down apparently healthy young people are commonplace. Even patients who do not die of the infection show a huge spread in their symptoms: Some never get sick; some need to be hospitalized but recover; some have lingering disabilities that last for months.

So far, scientists have been largely at a loss to explain why COVID-19 hits patients as hard as it does, though reasons surely exist. Its not just bad luck, said Helen Su, an immunologist at the National Institute of Allergy and Infectious Diseases.

One possibility under investigation is that some people harbor genes that put them at greater or lesser risk from COVID-19. The COVID Human Genetic Effort, for example, is enrolling hundreds of patients from around the globe who wound up in intensive care after infection with the SARS-CoV-2 virus. Initially, the project only enrolled patients who were under age 50 and had no underlying health conditions, though it has more recently expanded eligibility.

My hope is to understand the genetic basis of severe COVID in patients of all ages and regardless of comorbidities, said Jean-Laurent Casanova, a researcher in pediatric medicine and immunology at the Rockefeller University who co-founded the project with Su and others. And from that, to understand the mechanism that makes them vulnerable to SARS-CoV-2.

Some genetic clues may already be coming to light. Last week, a team of researchers in the Netherlands published a preliminary communication online in JAMA about four young male patients from two families who all suffered severe COVID-19 respiratory illnesses. The men, who were between the ages of 21 and 32, had no history of chronic medical problems, but DNA sequencing revealed that each of them had a rare form of a gene on his X chromosome that was linked to a deficient immune response. Much more study will be needed to determine whether similar deficiencies, possibly involving other genes, are common among COVID-19s worst cases.But in a study appearing in Nature today, researchers at the Yale University School of Medicine who followed the progression of COVID-19 in 113 hospitalized patients for two months found that greater severity of the disease was associated with maladaptive immune responses. (The causes for those immunological misfires was not determined.)

The significance of these discoveries may not be limited to COVID-19. Casanova is a champion for an idea that has been slowly gaining credence among medical researchers for many years: that genetics is always a factor in infectious diseases. Many if not all people may have very specific genetic vulnerabilities, such as weaknesses in their immune system, that go unnoticed until one particular pathogen crosses their path. That genetic trait is their Achilles heel, and that pathogen is the one thing that can take advantage of it.

The theory has emerged out of both clinical practice and scientists growing appreciation of the interconnection between genes and infectious diseases. Casanova has spent the past 25 years scanning the genomes of young people who were inexplicably debilitated by commonplace pathogens like the herpes simplex and varicella zoster viruses (which cause cold sores and chickenpox, respectively). In these children, who showed no outward symptoms of compromised immunity, he has found defects in genes that make them susceptible to severe infection with a single pathogen. In most cases, there were no clinical signs of a genetic problem until they were infected.

For many of these immune deficiencies where children or adults have very severe infections there is a genetic basis, said Trine Mogensen, a physician at Aarhus University and a member of the COVID Human Genetic Effort steering committee.

If the COVID project succeeds in finding genes relevant to the course of the infection, it could fuel interest in widening that search for other conditions. Further work on the interplay of infections, immunity and genomes could change how future gene-based medicine routinely diagnoses and treats diseases.

Infectious disease has always been one of greatest threats to humanity. Before the invention of antibiotics, infections killed half of all children by age 15. Yet as terrible as their collective toll has been, even the worst infectious diseases kill relatively few of those they infect. Tuberculosis has been a scourge, but fewer than 10% of people infected with it even get sick. Even the terrible Spanish flu pandemic that started in 1918 had a mortality rate often estimated at around 2.5%.

Variability in disease severity is usually chalked up to circumstantial factors: the virulence of different pathogen strains, the amount of pathogen exposure, the nutrition or general health of a patient. Researchers have suspected, however, that something more is lurking in the genes of the hardest-hit patients.

The idea of a genetic component to infection dates back to 1905, when an English scientist named Rowland Biffen discovered a gene responsible for a devastating fungal disease called yellow rust that was killing wheat and diminishing crop yields across England. He found that resistance to the fungus was present in some of the plants as a recessive trait passed down from parent to offspring without affecting other characteristics of the plant. The discovery was celebrated, and his method of breeding for resistant plants is still widely used today.

These types of genes were later found in other plants and animals. But genetic immunodeficiencies in humans didnt start to attract attention until the 1950s, when an immune disorder was identified in an 8-year-old boy being treated at Walter Reed Army Medical Center for recurrent blood infections. The disorder, known as X-linked agammaglobulinemia, inhibits the bodys ability to make the antibodies called gamma globulins, resulting in severe infections even from fairly innocuous pathogens.

The boy had suffered 19 bouts of pneumococcal meningitis, which were repeatedly treated with antibiotics. His condition improved more lastingly only after his physician, Ogden Bruton, discovered that the boy had almost no gamma globulins in his blood. Bruton promptly began treating him with monthly injections of gamma globulins, and the boy survived to adulthood. The discovery, which was described in Pediatrics in 1952, was later recognized as a milestone, highlighting the role of defects of the immune system in inhibiting the fight against infection. These defects were later termed inborn errors of immunity.

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Omega Therapeutics Lands $85M to Tap Into Control Room of Biology – Xconomy

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The promise of gene therapies and gene-editing drugs is a long-lasting treatment thats potentially a cure. But making permanent genetic changes means any accompanying problems could be long-lasting as well, says Omega Therapeutics CEO Mahesh Karande.

Omega is developing technology that takes a more nuanced approach to genomic medicine. Instead of fixing or replacing faulty genes, the company aims to harness the biological system that regulates them. If a gene is not properly translating DNA instructions into a needed protein, Omega can tune the gene expression up, Karande says. If gene expression is too high, the companys technology dials it down.

We have basically tapped into the control room of biology, says Karande, a former executive at Macrolide Pharmaceuticals and Novartis (NYSE: NVS). Our therapeutics are allowing genes to express at their native, correct level of expression. We tap into that biology.

Now the Cambridge, MA-based biotech has tapped into something more: $85 million in financing. Karande says the cash will support multiple programs, the first of which is expected to reach clinical testing in 2021.

The system that regulates genes is called the epigenome. The targets of Omegas drugs are insulated genomic domains (IGDs), three-dimensional structures that rise up from the folds of DNA. IGDs regulate the activity of a gene, similar to the way a thermostat regulates the temperature of a room, the company says. Omega has developed technology that identifies IDGs and their biological functions in states of both health and disease.

Omegas drugs are fusion proteins made up of a delivery system that takes the therapy to specific cell types, a targeting domain that binds to a specific site on the IGD, and a functional domain engineered to tweak the activity level of the IGD as needed. A single Omega drug can control the gene expression of a single gene or multiple genes, Karande says. The company can also control the length of time that a drug works, making it last days, weeks, or longer. That makes the treatment applicable for acute conditions of short duration. And unlike the permanent change made by genomic medicines, if an epigenomic Omega therapy is no longer needed, it can be turned off.

Most gene therapies and gene-editing drugs are delivered by engineered viruses. In addition to hitting the intended genetic target, these viruses can also hit other places, causing side effects, says Tom McCauley, Omegas chief scientific officer. Also, gene-editing drugs use cutting enzymes that can snip unintended spots along the genome, sparking off-target effects. By contrast, Omegas targeted approach gives its drugs the potential to more safely treat genomic disorders with a degree of control not offered by gene therapies or gene-editing drugs, McCauley says.

There are other epigenetic medicines companies. Cambridge, MA-based Epizyme (NASDAQ: EPZM) is developing drugs addressing the genetic causes of disease. In January, the FDA approved the companys small molecule drug tazemetostat (Tazverik) as a treatment for the rare cancer epithelioid sarcoma. In June, it won an an additional nod for follicular lymphoma. The most advanced drug candidate, developed by another Cambridge-based epigenetics biotech, Constellation Pharmaceuticals (NASDAQ: CNST), is a small molecule in mid-stage testing in myelofibrosis, a rare blood cancer.

Theres a reason that most of the epigenetic medicines currently available and in drug pipelines are small molecules addressing some form of cancer, McCauley says. Those drugs do hit their cancer targets but they also go elsewhere in the body, sparking side effects, he says. That risk is acceptable in rare cancers, but untenable for other diseases. Cancer is one of Omegas disease targets, but McCauley says that Omegas capability to modulate the epigenome could more safely and effectively address other diseases as well.

The IDG science that is the basis for Omegas epigenomic approach stems from the research of Richard Young and Rudolf Jaenisch, MIT biology professors and members of the Whitehead Institute for Biomedical Research. In 2016, their research was published in the journal Cell. They are both scientific advisors to Omega, which was founded in 2017 by venture capital firm Flagship Pioneering, the companys only disclosed financial backer. The firm has a track record of starting companies, incubating them, and then spinning them out to advance their research.

Omega emerged from stealth last September. Karande would not say much about the companys disease targets then, and hes saying only a little more now. Without naming specific conditions, Karande says his startup aims to treat inflammatory and immunological disorders, metabolic conditions, and rare diseases where a targeted approach to modulating the epigenome enables the company to hit disease targets previously considered undruggable. The company currently has five programs. Karande says the new financing is enough to support all five, though he leaves open the possibility that some of them could be advanced in partnership with a large pharmaceutical company.

Were on a journey right now to get five programs, in a staggered fashion, into the clinic, he says. As we make milestones in the next few months, we will be talking about them.

Image: iStock/artisteer

Frank Vinluan is an Xconomy editor based in Research Triangle Park. You can reach him at fvinluan@xconomy.com.

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EarlyBird Study: Early Detection of Adult-Onset Type 2 Diabetes in Youth – Diabetes In Control

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Editor: David L. Joffe, BSPharm, CDE, FACA

Author: ChardaeWhitner, 2020 PharmD. Candidate, Lake Erie College of Osteopathic Medicine

The EarlyBird study investigated how to predict future pre-diabetes and type 2 diabetes in children.

Years of research have shown us that there are many factors that predispose patients to type 2 diabetes. However, researchers at the University of Plymouth, in collaboration with Nestl Institute of Health Sciences, monitored children to gain more insight into the factors that predispose them to type 2 diabetes in adulthood.TheEarlyBirdstudy, which is a prospective cohort study, investigated the genetic risk markers of type 2 diabetes in healthy children, as well as the influence trajectory of insulin and glucose independently of BMI.

EarlyBirdfollowed 300 children from the ages of 5 to 16 years old to determine who would become at-risk for developing type 2 diabetes, and why.Annual clinical anthropometric and physiological measurements were taken from the children. Researchers were among the first to report an early occurrence of -cell dysfunction in children who later developed pre-diabetes.This study also showed impaired fasting glycemia in subjects by the age of 15 years; these children had previously exhibited high blood glucose levels at the age of 5. The genetic variants, puberty, and weight gain were also analyzed byEarlyBirdto see how these factors could influence insulin action and blood glucose levels at an early age.

Results from this studyproved to be signicant because they reveal the changes in insulin secretion, insulin action, and glycemia over time. Genetic linkage of the SNPs associated with adult diabetes was mirrored in the children in their association with insulin and glycemic traits. SNPs susceptibility also showed age-specic interactions in the child subjects, with some of these traits including: rs780094(GCKR), rs4457053(ZBED3), rs11257655(CDC123), rs12779790 (CDC123 and CAMK1D), rs1111875 (HHEX), rs7178572 (HMG20A), rs9787485 (NRG3), and rs1535500 (KCNK16). Many of the common genetic variants were associated with a variety of high levels of fasting blood glucose.

GCKR and ZBED3 were two intronic genetic variants that were associated with different trajectories of fasting blood glucose from an early age throughout childhood.An increased risk of developing type 2 diabetes showed some correlation from the SNP ZEBD3 through elevated WNT activity.This pathway is controlled by short-chain fatty acids produced during the digestion of dietary fiber. ZEBD3 is known to affect fiber intake, which has led to the belief that this SNP is a relevant genetic maker for children who would benefit from increased consumption of dietary intake. GCKR is believed to be associated with lower fasting blood glucose levels in adults. In this study, it was found that the GCKR genotype was negatively associated with an age-dependent course of glucose; however, children at the age of 5 years old showed a positive association with blood glucose.

One of the most pivotal discoveries in this study is that relative defects in -cell function were a determining factor for who developed pre-diabetes. HOMA-B (-cell function) carried the most genetic associations of diabetes susceptibility. SNPs in the CDC123, HHEXIDE, and KCNK16 loci, showed a negative association with HOMA-B. SNPs in the CDC123 loci may represent that there is-cell mass and can influence function throughout growth. Evidence from theEarlyBirdstudy showed that that the interactions of the SNP in HHEXIDE loci with the trajectories of SHBG, IGF-1, and 17-OHP may inuence endocrine traits and therefore the maturation of other biological processes in childhood.Through these findings, it is believed that insulin action is alsoinuenced by genetic variations in the growth hormoneIGF-1 axis and adrenal and sex steroid activity, with a negative association in both HOMA-B and SHBG (sex hormone-binding globulins). Since the HHEX IDE SNP relates to insulin secretion capacity in early life, it is believed that there are effects beyond fetal development into pubertal growth and development.

TheEarlyBirdstudy was successful in demonstrating that SNPs previously associated with diabetes in adults also can be influential in children with the course of glycemic and insulin traits, independent of BMI.

Practice Pearls:

Carayol, J. et al.(2020) Genetic Susceptibility Determines -Cell Function and Fasting Glycemia Trajectories Throughout Childhood: A 12-Year Cohort Study (EarlyBird76).Diabetes Care.doi.org/10.2337/dc19-0806.

ChardaeWhitner, 2020 PharmD. Candidate, Lake Erie College of Osteopathic Medicine

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More:

EarlyBird Study: Early Detection of Adult-Onset Type 2 Diabetes in Youth - Diabetes In Control