With help from Myah Ward and Ryan Heath

NEEDLE IN A HAYSTACK Results from two front-running Covid vaccine candidates one from a joint Oxford University-AstraZeneca team, the other from Chinas CanSino Biologics were published today in the Lancet. The early results show that the two candidates produced an immune response in people.

Heres what we learned: The Oxford vaccine produced a promising immune response that lasted for nearly two months in an early study of more than 1,000 healthy adults. Likewise, most participants in a 500-person trial of CanSinos vaccine, which tested two dose strengths, showed an immune response.

Heres what we still dont know: What immunity to the virus looks like. Participants in both trials developed Covid-19 antibodies, and volunteers in Oxfords trial also produced more of the white blood cells known as T cells. Scientists think both antibodies and T cells could be important protectors against the virus, but they dont know what level of each we might need to fend off infection. Antibodies, produced by another type of white blood cell called B cells, are proteins that bind to foreign invaders like viruses to keep them from infecting our cells. T cells kill cells once they are infected.

Months into the pandemic, researchers are still learning how the immune system responds to the virus. No other viruses appear to provoke such a wide range of reactions. Up to 40 percent of people who are infected show no symptoms, while others suffer everything from lung failure to neurologic symptoms and die. Its an exceptionally different virus than any that appeared to date, said Eric Topol, executive vice president and professor of molecular medicine at Scripps Research Institute, a nonprofit biomedical research facility based in San Diego.

In other ways, this coronavirus is less tricky than other viruses: Compared to viruses like HIV the coronavirus has much less diversity on the genetic level, said Dave OConnor, professor of pathology and laboratory medicine at the University of Wisconsin. Its the same shape in nearly everyone. OConnor doesnt think that we will need a new vaccine every year like the flu because of virus shape changes, but we might need occasional boosters.

We still dont know whether Covid survivors can become reinfected, or how long their immunity to the virus lasts. But those questions could become irrelevant once a vaccine is discovered, said Akiko Iwasaki, a Yale immunobiologist. A vaccine is often better at producing long-term immunity than surviving an infection is. A vaccine, unlike a natural infection, can boost the immune response to the level where it becomes protective, said Iwasaki. In the end its really the efficacy that matters.

Heres what to look for next: CanSinos decision to use a weakened common cold virus as the base of its vaccine could undermine the shots effectiveness. The study today revealed that people who had previously been exposed to the cold virus showed weaker immune responses to the coronavirus vaccine presumably because their immune systems zeroed in on the familiar component of the vaccine, the weakened cold virus, rather than SARS-CoV-2.

Older people, whose immune systems are less vigorous, also showed a weaker response to the vaccine.

Large end-stage trials of both vaccines are underway in tens of thousands of people, and should reveal whether the shots work. Scientists will track rates of infection among people who get the vaccines versus those who dont. Results are expected in the next several months. Stay abreast of the latest developments with POLITICOs vaccine tracker.

Welcome to POLITICO Nightly: Coronavirus Special Edition. Anthony Fauci is throwing out the first pitch for the Washington Nationals season opener on Thursday. Reach out [emailprotected] or on Twitter at @renurayasam.

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Our global team is going full speed to develop potential therapies that may help treat COVID-19. At the same time, were collaborating on innovative vaccine candidates that can be made by the millions. Discover what were doing right now.

FOOD FIGHT The Trump administration is resisting calls to make it easy for tens of millions of students to get free meals at school this year, even as childhood hunger rates have risen to the highest levels in decades. During the spring and summer, as the coronavirus health crisis exploded, the government allowed most families to pick up free meals from whichever school was closest or most convenient without proving they are low-income, Helena Bottemiller Evich and Juan Perez Jr. write. But that effort is on the verge of expiring. School systems are pushing the federal government to continue the free meals program through the fall.

So far, Trumps Agriculture Department isnt on board. School leaders are now asking Congress to force the administrations hand as lawmakers buckle down to work on the next coronavirus aid package.

MORTALITY VS. FATALITY In an interview with Fox News Chris Wallace on Sunday, President Donald Trump said the U.S. has one of the lowest mortality rates anywhere in the world, while Wallace said the U.S. has one the worst. One reason for the confusion: Wallace was talking about mortality rates, while the president was referring to a measurement called the case fatality rate, Nightlys Myah Ward writes.

Whats the difference? The mortality rate is the number of Covid deaths among all people in a given population over a period of time. CFR measures the number of deaths among people with Covid. It is a measure of the diseases severity, how likely it is this might kill me, said Abraar Karan, a physician at Harvard Medical School and Brigham and Women's Hospital.

Mortality rate is kind of the standard terminology we use when were talking about how many people die from a disease, typically in the setting of chronic diseases, said Ellie Murray, a professor of epidemiology at Boston University School of Public Health.

And thats because if were thinking about something like cancer you have cancer, you dont have cancer, she said. But infectious diseases are a bit weirder than chronic diseases in that you can be infected and never really get the disease.

The news media and others not familiar with infectious disease often use mortality rate as an umbrella term, and this can be misleading, Murray said. So which measurement should we be using?

The Johns Hopkins data used by Wallace during the interview is really only useful for comparing between countries, Murray said, because it gives you the sense of, standardized to the population sizes of different countries, how big is the outbreak?

But to see how a country is doing with finding cases and treating sick people, look at the case fatality rate, Murray said. The more cases you find, the lower that number will go, she said. And so you can kind of get that case fatality rate number down by finding more mild cases and doing better treating the cases that you have.

BRIEFINGS ARE BACK Trump said today he would resume holding coronavirus briefings after a nearly three-month hiatus. A constant presence during the spring, the briefings were curtailed in late April. The last one featured Trumps unfounded speculation that injecting disinfectants could ward off the virus. Trump told reporters gathered in the Oval Office this morning that the next coronavirus briefing would likely be held on Tuesday at 5 p.m. Eastern time.

AT THE TABLE Trump and top administration officials are continuing to push for a payroll tax cut but Republican leaders on Capitol Hill havent signed off on the proposal as Congress begins work on a new coronavirus relief package, Marianne LeVine, Andrew Desiderio and John Bresnahan write.

Trump and Republican leaders in Congress are united on reducing unemployment insurance payments as part of their newest stimulus proposal, and they will call for additional direct payments to Americans as part of a $1 trillion package expected to be unveiled this week.

The negotiations kicked off today as lawmakers returned to Washington after a two-week recess that saw massive spikes in coronavirus cases in many states.

Senate Republicans are also pushing for tens of billions of dollars in funding for testing and additional funds for the CDC, in addition to spending boosts for the State Department and Pentagon money that the White House so far has resisted including in the new package. Trump administration officials have also floated new spending caps for next years budget, and they are seeking funding for non-coronavirus projects, such as $250 million for FBI renovations, said GOP lawmakers and aides.

STILL NOT CLOSE The sheriff of Jacksonville, Fla., said he cant provide security for the Republican National Convention because of a lack of clear plans, adequate funding and enough law enforcement officers, Marc Caputo writes. As we're talking today, we are still not close to having some kind of plan that we can work with that makes me comfortable that we're going to keep that event and the community safe, Duval County Sheriff Mike Williams told POLITICO.

Williams, a Republican, wouldnt definitively say there is no way the event could be held. But he said he had grave doubts about it, especially in an era of heightened protests concerning police use of force. Williams said the event, scheduled for Aug. 24-27, was announced in June, giving his agency little time to plan and prepare.

DeSANTIS, TEACHERS HEAD TO COURT Floridas largest teachers union sued Republican Gov. Ron DeSantis and state Education Commissioner Richard Corcoran to overturn a sweeping emergency order that requires schools to physically open five days a week, saying the policy bypasses local leaders and defies national public health guidelines, Florida education reporter Andrew Atterbury writes.

The complaint, filed in circuit court in Miami-Dade County, comes as the Republican governor sought to distance himself from the order, which was issued July 6.

DeSantis put the order squarely at Corcoran's feet today and said it was meant to give parents the option of sending their children back to school. I didnt give any executive order, that was the Department of Education, DeSantis told reporters.

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GETTING TESTED IN MIAMI Trade reporter Sabrina Rodriguez emails us:

After six months away from my 90-year-old abuela, I decided it was time to ditch D.C. and drive to Miami more specifically, my hometown of Hialeah, Fla., the U.S. city known for having the highest population of Cubans and Cuban Americans outside the Communist-run island.

It took a 15-hour drive, not including a couple breaks at sketchy rest stops. Once I made it, I went straight to a friends vacant apartment to isolate for a few days before going to get tested. I spent days on the phone and online trying to schedule an appointment through the Miami-Dade County Department of Health with no luck, so I resorted to driving to Miami Beach for an appointment-free, drive-thru testing site.

I braced for a massive wait after hearing about friends who sat in their car for more than three hours waiting for a test. But I was done within 50 minutes 25 minutes of which were spent in my car before a member of the Florida National Guard knocked on my window and asked if I wanted to park to take a walk-up test, where there were only six people in line.

That same member of the National Guard (who frankly was not very well versed in social distancing, and kept trying to hand out bottles of water with his bare hands) said the drive-thru line had stretched out about a mile, with a three-hour wait, earlier in the day.

Waiting for my results was another story. After six days, my results came via text message. I almost had completed a 14-day quarantine a day of driving, five days of trying to schedule a test, six days of waiting for my results by the time I found out I tested negative. Now, Im finally reunited with my abuela and my mother.

Nightly asks you: Have you gotten tested for Covid-19? Do you want to get tested but are unable to? Tell us your testing experience. Send us your story with our form and well include some of the responses in Fridays Nightly.

STILL VACANT Summer holidays along the Aegean Sea have always been popular in Europe, but Greeces large tourism economy hasnt seen much of a comeback, Nektaria Stamouli writes. The Greek government opened the countrys borders in mid-June, under pressure from the tourism sector, which makes up 20 percent of the countrys economy. While Greeces Covid numbers dont look bad 194 deaths and about 4,000 infections the move has forced mandatory mask-wearing in spaces like supermarkets starting this week, without anything like the economic boost tourism operators hoped for. Hotels are reporting occupancy rates at 30 percent or lower.

Parisians watch the opening night of a floating cinema in Paris. Thirty-eight electric boats were installed along the Seine river in compliance with social distancing rules, with 150 deckchairs on the banks of the canal, to screen films. | Getty Images

$35 million

The amount of money outside vendors have received for work on the new data system, HHS Protect, that the health department is using to restore public access to coronavirus data. Officials say they have implemented safeguards to prevent tampering, such as keeping a record of all changes that were made.

ADIOS TO OL? In bullfighting, the dying animal is put out of its suffering with a quick dagger blow by the puntillero. Now, after years of decline, the whole industry may be about to receive its own death blow at the hands of the coronavirus.

The pandemic struck Spain in March, just as the bullfighting season was about to get underway. A strict lockdown was introduced for the next three months, meaning the cancellation of all events, including major ones such as Sevilles Feria de Abril and San Isidro in Madrid. Although in recent weeks the country has returned to a normality of sorts, with businesses, theaters and cinemas reopening and top-tier football resuming, bullfighting is still in limbo.

This is a disaster of unprecedented dimensions, weve not seen a situation like this one in the history of bullfighting, said Antonio Lorca, who covers the sport for El Pas newspaper. Theres even a risk it will disappear altogether. Technically, bullfights are now allowed again, although regional governments must impose safety restrictions, such as limiting the number of people allowed to attend and ensuring there is social distancing between them. This and the uncertainty that reigned throughout the spring has meant that the vast majority of the summers events have been canceled.

A message from Emergent BioSolutions:

We go after public health threats. In the fight against COVID-19, we are going full speed to develop potential new therapies and vaccine candidates.We go for critical innovations. We are developing two potential hyperimmune treatments for severe hospitalized COVID-19 patients and individuals at risk. Based on proven technology, the research and testing are underway.We go in partnership with others. We are working with industry innovators to bring COVID-19 vaccine candidates to market. We have the capacity to manufacture vaccines in the tens to hundreds of millions, and we are propelling development forward.We go. And go. From fighting anthrax to helping prevent smallpox and developing vaccine candidates, we go all in. Because public health threats will never stop. And neither will we.

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Vaccines: What we know and what we don't - Politico

ORLANDO, Fla.--(BUSINESS WIRE)--A first-of-its-kind study to help treat Urinary Tract Infections (UTIs) is underway through a research partnership with one of the worlds leading medical experts in treating UTIs and a company that uses advanced DNA technology to identify microbes that cause infection so that doctors can target precise medical treatment.

Dr. J. Curtis Nickel, Research Chair in Urologic Pain and Inflammation at Kingston General Hospital Kingston, Ontario, Canada, is working with MicroGenDX, an Orlando, Fla.-based company that operates a high complexity diagnostic laboratory, to establish a baseline for what microbes are present on normal urine that is urine from those not currently experiencing any type of infection.

"The future of managing infectious disease in Urology will involve determining the pathogenic ecology of the lower urinary tract obtained with non-culture molecular diagnostic technology, such as Next Generation Sequencing (NGS), said Dr. Nickel. Until we know what the normal microbiome looks like in healthy individuals, it will remain difficult to interpret NGS microbiome results from urine specimens submitted by symptomatic patients.

Other medical experts are also excited about this groundbreaking research. "Our microbiome plays a pivotal role in our health and survival, yet we really dont know what normal is for the urinary tract of men and women, said Dr. E. David Crawford, Professor of Urology at University of California San Diego. This is one of the most important clinical studies to date in this area. I encourage healthy individuals to be a contributor to this study.

UTIs are the most common outpatient infections in women today, according to a recent peer-reviewed article in Therapeutic Advances in Urology. UTIs will affect 5060% of adult women, with women over 65 experiencing almost double the rate as the female population overall. As many as one-in-five women suffer from recurrent UTIs, those that occur at least twice in six months or three times per year. While UTIs are more common among women, men can also fall victim to these stubborn infections. According to the National Kidney Foundation, UTIs account for some 10 million healthcare visits per year.

The driving force behind the study is MicroGenDX, which identified the need for this research, collaborated with Dr. Nickel in its design and managed the FDA-required Institutional Review Board process required for this type of medical research. Additionally, MicroGenDX is donating approximately $120,000 in lab services for collection, shipment and analysis of samples.

Our support of this research is a part of our ongoing effort to advance the science of detecting, identifying and treating viral, bacterial and fungal infections, said MicroGenDX CEO Rick Martin. We are honored to be working with the worlds leading experts and look forward to the findings of this study, which will help improve the lives of those suffering with recurrent UTIs.

In order to participate in the study, a person should be in good urological health and cannot have taken any antibiotic or antifungal medication for the past three months. Those wishing to participate in the study just need to complete an online questionnaire. Those selected for the study will be sent a urine collection kit, which can be used at home and returned in a prepaid package to MicroGenDX. There is no cost to participate, and each participant will receive his or her results. Those wanting to participate or learn more about the study can go to https://microgendx.com/healthymicrobiomestudy/. Researchers hope to conclude the study later this year.

About Dr. J. Curtis Nickel

J. Curtis Nickel, MD, FRCSC, is Professor of Urology and Research Chair in Urologic Pain and Inflammation at Kingston General Hospital Kingston, Ontario, Canada. He has over 550 publications, is on the editorial board of eight Urology journals, editor of the AUA Update Series, presented in 45 countries, funded by US NIH and Canadian CIHR and was awarded a CIHR Tier I Canada Research Chair (until 2021), AUA Distinguished Contribution Award and SIU Academy Award. He is currently Immediate Past-President of the Canadian Urological Association.

About MicroGenDX

MicroGenDX is a College of American Pathologists (CAP) accredited and Clinical Laboratory Improvements Amendments (CLIA) licensed clinical laboratory with more than 12 years of experience in diagnosing molecular-based, laboratory-developed tests. MicroGenDX operates a high-complexity diagnostic laboratory that uses Next Generation DNA Sequencing Technology (NGS Technology) rather than the traditional approach of growing cultures to determine the presence of and identify by their genetic markers specific micro-organisms that are the cause of infections.

MicroGenDXs technology and mission are improving and saving the lives of patients with serious and often chronic infections and diseases by using the latest science and the most precise diagnostic tool available to identify the cause of infection so that the most effective medicine can be prescribed to treat that infection. Thousands of patients with chronic and often life-threatening infections have benefited from MicroGenDXs work.

The rest is here:

MicroGenDX Advances Research for Breakthrough Treatments of Urinary Tract Infections - Business Wire

The inactive ingredients found in medication, including things like fillers and dyes, may not be as inactive as they seem, according to a new study. Some of these compounds may have an active effect on the body and, in some cases, may be harmful, the research suggests. Though inactive ingredients are often an important part of various drugs, the study suggests that additional research is necessary to determine their individual effects.

Medication is often composed of two types of ingredients: the active compound and excipients, which are inactive compounds used for things like delivering the active ingredients. In most cases, tablets and certain other types of medication contain more excipients than active ingredients, though that doesnt mean they arent a necessary part of the overall drug delivery.

The new study out of the American Association for the Advancement of Science warns that while most excipients are indeed inactive, some may have an impact on the parts of the body targeted by active ingredients, including things like receptors and enzymes.

The inactive ingredients are studied on animals for potential toxicity, but the new study warns that there isnt much research on whether these compounds also impact the medically relevant molecular targets. As part of the research, it was found that 38 approved inactive ingredients have 134 effects on molecular targets that were previously unknown.

Of particular relevance is that a minority of excipients may have a harmful effect, with the study noting that:

several excipients exhibit evidence predictive of tissue-level toxicity in cellular models. While most of these are suspected not to reach dangerous exposure levels, the results suggest that two thimerosal and cetylpyridinium are capable of reaching in vivo concentrations, that overlap their in vitro binding activity to the dopamine receptor D3.

Ultimately, the study found that additional research into the potential impact of these active ingredients toxicity aside is necessary to determine whether some inactive ingredients may have their own direct effects on the body.

Link:

Inactive medicine ingredients may be actively harmful, study warns - SlashGear

SAN DIEGO, July 23, 2020 (GLOBE NEWSWIRE) -- Progenity, Inc. (Nasdaq: PROG), a biotechnology company focused on providing complex molecular and specialized diagnostic tests to clinicians as well as innovating in the field of precision medicine, today announced that it has entered into agreements with the Department of Justice (DOJ) and the Department of Health and Human Services that resolve civil and criminal investigations by such agencies related to certain past business, promotional, and billing practices. After reviewing the Companys extensive remediation and cooperation efforts, among other considerations, the DOJ determined not to prosecute Progenity and instead entered into a non-prosecution agreement in parallel with civil settlements.

We are very pleased to resolve this matter as it allows us to move forward and concentrate on our mission to be a crucial provider of cutting-edge diagnostic testing and precision medicine, said Harry Stylli, PhD, CEO, chairman of the board, and co-founder of Progenity. Over the past two years, Progenity has implemented an overhaul of our compliance program and has transitioned from an out-of-network to primarily an in-network provider. These actions included engaging third parties to review our compliance policies and procedures, revamping internal controls to guarantee accurate and consistent coding, and changing our leadership team, including hiring a new Chief Compliance Officer, Chief Operating Officer, Chief Financial Officer, Chief Commercial Officer, and Chief Information Officer. We also appointed a new independent board with extensive industry experience in areas including reimbursement, regulatory, and compliance.

As described by the agreements, Progenity has committed to pay $35.8 million to settle the federal claims. Certain of the government agreements also obligate the Company to continue its enhancements to internal controls and its compliance program, while noting the Companys remediation and cooperation efforts to date. The Company expects to pay an additional $13.2 million to settle outstanding claims by state Attorneys General.

As the government recognized, Progenity has made significant strides in compliance policies and controls, accepting full responsibility for the historical misconduct at issue, said Stylli. Were excited to turn the page and focus fully on what we do best: providing valuable, industry-leading testing services to clinicians and developing our innovative precision medicine capabilities.

About ProgenityProgenity, Inc. is a biotechnology company with an established track record of success in developing and commercializing molecular testing products, as well as innovating in the field of precision medicine. Progenity provides in vitro molecular tests designed to improve lives by providing actionable information that helps guide patients and physicians in making medical decisions during key life stages. The company applies a multi-omics approach, combining genomics, epigenomics, proteomics, and metabolomics to its molecular testing products and to the development of a suite of investigational ingestible devices designed to provide precise diagnostic sampling and drug delivery solutions. Progenitys vision is to transform healthcare to become more precise and personal by improving diagnoses of disease and improving patient outcomes through localized treatment with targeted therapies. For more information on how Progenity is helping clinicians and patients prepare for life, please visit http://www.progenity.com.

Forward Looking Statements

This press release contains forward-looking statements within the meaning of the federal securities laws, which statements are subject to substantial risks and uncertainties and are based on estimates and assumptions. All statements, other than statements of historical facts included in this press release, including statements concerning the timing and amount of settlement payments and the effectiveness of Progenitys compliance protocols and reporting standards, are forward-looking statements. In some cases, you can identify forward-looking statements by terms such as may, might, will, objective, intend, should, could, can, would, expect, believe, design, estimate, predict, potential, plan or the negative of these terms, and similar expressions intended to identify forward-looking statements. These statements involve known and unknown risks, uncertainties and other factors that could cause the Companys actual results to differ materially from the forward-looking statements expressed or implied in this press release, including those described in Risk Factors and Managements Discussion and Analysis of Financial Condition and Results of Operations in Progenitys Registration Statement on Form S-1 (File No. 333-238738), as amended, filed with the U.S. Securities and Exchange Commission. Progenity claims the protection of the Safe Harbor contained in the Private Securities Litigation Reform Act of 1995 for forward-looking statements. Progenity expressly disclaims any obligation to update or alter any statements whether as a result of new information, future events or otherwise, except as required by law. Until the final settlement agreements are approved and signed by the states, there can be no assurance that the amount we have accrued will be sufficient to cover Progenitys obligations relating to this matter. Progenitys obligations could also increase, potentially materially, depending on a number of factors including whether or not the agreement on the monetary terms with the states is finalized, whether an individual state or states opt out of the settlement prior to approval in order to pursue a separate action or resolution, the terms of the final approved agreements and the parties to the settlement. For additional information, please see Note 9. Commitments and Contingencies to Progenitys audited financial statements for the year ended December 31, 2019, in the Registration Statement, as well as Risk FactorsRegulatory Risks Related to Our BusinessIf we or our commercial partners act in a manner that violates healthcare laws or otherwise engage in misconduct, we could face substantial penalties and our business operations, and financial condition could be adversely affected.

Investor Contact:Robert UhlManaging Director, Westwicke ICRIR@progenity.com(619) 228-5886

Media Contact:Kate Blom-LoweryCG Lifekblomlowery@cglife.com(619) 743-6294

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Progenity Reaches Resolution with Government Related to Past Business, Promotional, and Billing Practices - GlobeNewswire

IRVINE, Calif. and EDISON, N.J., July 22, 2020 /PRNewswire/ --Hackensack Meridian Health (HMH) in Edison, New Jersey, and Genomic Testing Cooperative (GTC), Irvine, California, announced today an agreement to establish a next generation sequencing reference laboratory for molecular profiling. The state-of-the-art laboratory, located at JFK Medical Center in Edison, New Jersey, will use artificial intelligence software and algorithms developed by GTC.

The new genomic laboratory will be initially focused on cancer and will expand to immune diseases and various chronic diseases. It will bring genomics to the currently active screening and prevention program at HMH. Recent innovation in diagnostic testing, called molecular testing, provides a deeper insight into tumors' genomic signature. Molecular tests are looking for alterations in the cancer's DNA and RNA that drive the disease's growth and spread. Testing could reveal one cause or several causes that may offer insights into how the tumor will behave. The goal of the tests is to offer diagnostic, prognostic and predictive information about targeted options.

This new facility will not only serve the physicians in the HMH network, but will provide outreach service to physicians and hospitals on the East Coast.

"Investing in genomics and establishing a reference laboratory in genomics represents a new phase for Hackensack Meridian Health and demonstrates our commitment to be a leader in improving patient care," noted Robert C. Garrett, FACHE, chief executive officer, Hackensack Meridian Health. "We believe that precision medicine based on genomics not only delivers better medicine but is more efficient and cost effective."

Maher Albitar, MD, chief executive officer and chief medical officer at GTC, stated, "Collaborating with HMH to open a reference laboratory on the east coast is a part of our plan in democratizing next generation sequencing and building a network of genomic laboratories that offer sophisticated high-quality molecular testing.These laboratories will use the same algorithms and artificial intelligence approach in analyzing data with cross validation, so the data can be grouped and used for developing new applications and new indications. This collaboration will allow GTC to co-develop new tests with HMH utilizing real world clinical and outcomes data provided by HMH."

"Paired DNA and RNA profiling is increasingly recognized as the new standard in precision medicine and GTC is leading in developing clinical utilizations for this approach. Although we are currently using genomic information for diagnostic and therapeutic decision-making, we are only touching the surface of how this technology can be applied," said Dr. Andre Goy, physician-in-chief for Oncology at Hackensack Meridian Health and chair of John Theurer Cancer Center. He added, "The collaboration between HMH and GTC will facilitate bringing this technology faster to everyday patient care."

"HMH is highly patient focused and GTC is a leader in genomic diagnosis and this partnering will not only represent a unique opportunity for advancing medicine and health outcome, but could have implicationson health policies as well," explained Mark Stauder, chief operating officer, Hackensack Meridian Health.

The new reference laboratory will complement the previously announced next generation sequencing laboratory operated by Regional Cancer Care Associates in their practice located at the John Theurer Cancer Center at Hackensack University Medical Center, which provides services for RCCA physicians.

Hackensack Meridian Healthis New Jersey's largest and most comprehensive health network.

ABOUT HACKENSACK MERIDIAN HEALTH

Hackensack Meridian Health is a leading not-for-profit health care organization that is the largest, most comprehensive and truly integrated health care network in New Jersey, offering a complete range of medical services, innovative research and life-enhancing care.

Hackensack Meridian Health comprises 17 hospitals from Bergen to Ocean counties, which includes three academic medical centers Hackensack University Medical Center in Hackensack, Jersey Shore University Medical Center in Neptune, JFK Medical Center in Edison; two children's hospitals - Joseph M. Sanzari Children's Hospital in Hackensack, K. Hovnanian Children's Hospital in Neptune; nine community hospitals Bayshore Medical Center in Holmdel, Mountainside Medical Center in Montclair, Ocean Medical Center in Brick, Palisades Medical Center in North Bergen, Pascack Valley Medical Center in Westwood, Raritan Bay Medical Center in Old Bridge, Raritan Bay Medical Center in Perth Amboy, Riverview Medical Center in Red Bank, and Southern Ocean Medical Center in Manahawkin; a behavioral health hospital Carrier Clinic in Belle Mead; and two rehabilitation hospitals - JFK Johnson Rehabilitation Institute in Edison and Shore Rehabilitation Institute in Brick.

Additionally, the network has more than 500 patient care locations throughout the state which include ambulatory care centers, surgery centers, home health services, long-term care and assisted living communities, ambulance services, lifesaving air medical transportation, fitness and wellness centers, rehabilitation centers, urgent care centers and physician practice locations. Hackensack Meridian Health has more than 34,100 team members, and 6,500 physicians and is a distinguished leader in health care philanthropy, committed to the health and well-being of the communities it serves.

The network's notable distinctions include having four hospitals among the top 10 in New Jersey by U.S. News and World Report. Other honors include consistently achieving Magnet recognition for nursing excellence from the American Nurses Credentialing Center and being named to Becker's Healthcare's "150 Top Places to Work in Healthcare/2019" list.

The Hackensack Meridian School of Medicine at Seton Hall University, the first private medical school in New Jersey in more than 50 years, welcomed its first class of students in 2018 to its campus in Nutley and Clifton. Additionally, the network partnered with Memorial Sloan Kettering Cancer Center to find more cures for cancer faster while ensuring that patients have access to the highest quality, most individualized cancer care when and where they need it.

Hackensack Meridian Health is a member of AllSpire Health Partners, an interstate consortium of leading health systems, to focus on the sharing of best practices in clinical care and achieving efficiencies.

For additional information, please visit http://www.HackensackMeridianHealth.org.

About Genomic Testing Cooperative, LCA

Genomic Testing Cooperative (GTC) is a privately-owned molecular testing company located in Irvine, CA. The company operates based on a cooperative (co-op) business model. Members of the co-op hold type A shares with voting rights. The company offers its patron members a full suite of comprehensive genomic profiling based mainly on next generation sequencing. The co-op model allows GTC to make the testing and information platform available to members at a lower cost because of a lower overhead. For more information, please visit https://genomictestingcooperative.com/.

Forward Looking Statements

All of the statements, expectations and assumptions contained in this press release are forward-looking statements. Such forward-looking statements are based on the GTC and HMH management's current expectations and includes statements regarding the value of Molecular profiling, testing, therapy, and the ability of testing to provide clinically useful information. All information in this press release is as of the date of the release, and HMH or GTC undertakes no duty to update this information unless required by law.

Hackensack Meridian Health Contact:Katherine EmmanouilidisT:551-996-3764[emailprotected]

Genomic Testing Cooperative contact:Jennifer Varca (949) 540-9421[emailprotected]

SOURCE Genomic Testing Cooperative; Hackensack Meridian Health

Genomic Testing Cooperative | Next-gen sequencing

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Hackensack Meridian Health Partners with Genomic Testing Cooperative to Establish a Reference Laboratory Offering State-of-the-Art Genomic Precision...

This week we are hosting our annual MedCity INVEST conference online. Today is the last session of the event and includes the diagnostics track of the Pitch Perfect contest. The conference kicked off July 20. You can check out the agenda here.

At 3:30 p.m. five diagnostics startups will present their technologies in the final track of the week long Pitch Perfect competition in which healthcare startups pitch to a team of investor judges who question them about their businesses. They include:

SEngine leverages the convergence of modern technologies and functional precision medicine in the form of the PARIS Test, to deliver more effective, less toxic treatments to cancer patients and accelerate development of novel therapeutics.

CEO: Carla Grandori MD, PhD

Headquarters: Seattle, WA

Exogene Bio is a diagnostics and medical device company whose goal is to enter the liquid biopsy market in order to simultaneously isolate exosomes and cell-free biomarkers using proprietary nanofluidic technology. This technology will then be integrated into an automated medical diagnostic device for the simultaneous detection of multiple classes of cancers using early stage biomarkers contained within exosomes and in cell-free fractions of body fluids.

CEO: Anant Kamath

Headquarters: Iowa City, IA

Amplified Sciences is a molecular diagnostics company using ultra-sensitive molecular sensing technology with composition of matter IP. The first application early detection of pancreatic cancer is an assay that will quickly prove the investment thesis due to large unmet medical need and a favorable reimbursement path.

CEO: Diana Caldwell

Headquarters: Indianapolis, IN

Atom Bioworks is a pioneer and leader in practice PEST (Pattern-matching Enabled Sensing & Theraputics) medicine by creating nanoscale biosensing and theraputics platform powered by innovative DNA nanostructures.

CEO: Sherwood Yao

Headquarters: Cary, NC

Genomtec develops smartphone-size, fully automated genetic analyser based on patent pending optical heating technology. It can be utilized in 15-minute infection or mutation detection in personalized therapy.

CEO: Miron Tokarski

Headquarters: Wroclaw, Poland

The judges for the diagnostics track include:

, H.I.G. BioHealth Partners Vice President, Philips Ventures Investment Manager, Sante Ventures Senior Associate

Check out participants in thePitch Perfect competition here. Winners for each track will be announced on July 27on our website.

All the sessions will be recorded and be available to attendees upon request.

We will be doing more online events this year. Check our events page for updates to the agendas.

For questions about INVEST, contact Laura Kittredge: lkittredge@breakingmedia.com

Photo: Adam Taylor, Getty Images

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Today at MedCity INVEST virtual: Diagnostics startups take the spotlight in the pitching contest - MedCity News

Dublin, July 24, 2020 (GLOBE NEWSWIRE) -- The "Large Volume Wearable Injectors Market (5th Edition), 2020-2030: Focus on Bolus, Basal and Continuous Delivery Devices" report has been added to ResearchAndMarkets.com's offering.

This report features an extensive study of the current market landscape and the likely future evolution of these self-injection devices, over the next ten years. It specifically lays emphasis on the emergence of patient-centric, convenient, cost-effective and user-friendly wearable drug delivery solutions that are capable of administering large volumes of a drug subcutaneously, in the home-care setting.

One of the key objectives of the report was to estimate the existing market size and potential future growth opportunities for large volume wearable injectors. Based on parameters, such as the number of commercialized devices, number of devices under development, price of the device and the annual adoption rate, we have provided an informed estimate on the likely evolution of the market over the period 2020-2030.

The report also features sales forecasts for the overall large volume wearable injectors market with a detailed market segmentation on the:

Chronic diseases, such as diabetes, cardiovascular disorders, neurological disorders, autoimmune disorders and various types of cancer, are known to be the leading causes of death and disability across the world. The clinical conditions associated with these diseases affect patients' overall quality of life. In fact, according to the World Health Organization (WHO), over 50% of the global population is currently estimated to be suffering from at least one chronic disease.

The past few years have witnessed introduction of several innovative pharmaceutical interventions for the treatment of a number of such diseases. However, majority of the available treatment options require parenteral administration of the drug, frequent dosing, and involve repeated hospital visits.

Treatment administration via the parenteral route is also associated with various concerns, such as dosing errors, risk of microbial contamination and needlestick injuries. These are known to be the primary factors affecting medication adherence and, thereby, have a significant impact on therapeutic outcomes. Over the past few years, a number of companies have developed advanced therapeutic delivery solutions (such as autoinjectors, pen injectors, prefilled syringes) to overcome the challenges associated with the administration of both conventional and novel drug/therapy molecules.

In fact, these drug delivery devices can prove to be potential vehicles for drug administration in disease outbreaks/pandemics (such as the one being faced due to the novel corona virus/COVID-19). Amongst modern drug delivery practices, the concept of self-injection has facilitated the administration of medications outside the clinical setting. Such practices also allow reductions in healthcare costs and enable the optimal usage of healthcare resources.

Specifically, large volume wearable injectors used for subcutaneous drug delivery, have become a preferred choice for administration of drugs in the home-care setting. Variants of these wearable devices have been designed to administer highly viscous drugs (such as biologics) in large volumes (more than 1 mL), offering numerous dosing options (basal, bolus or continuous), integrated safety mechanisms, and an almost negligible risk of needlestick injuries. Such devices have captured the interest of several stakeholders in this industry and are being used for the administration of both insulin and non-insulin drugs.

The field is presently witnessing a lot of innovation, such as the development of integrated mobile applications with smart health monitoring, artificial intelligence algorithms and other interesting features (including provisions for reminders, and the ability to connect to web-based portals for sharing medical data with the concerned healthcare providers), visual/audible drug delivery confirmation notifications, automatic drug reconstitution, and error alerts. We believe that such efforts are likely to drive growth in this market over the coming years.

Amongst other elements, the report includes:

In order to account for future uncertainties and to add robustness to our model, we have provided three market forecast scenarios namely the conservative, base and optimistic scenarios, which represent different tracks of the industry's evolution.

The opinions and insights presented in this study were influenced by discussions conducted with several stakeholders in this domain. The report features detailed transcripts of interviews held with the following individuals:

Key Questions Answered

Key Topics Covered

1. Preface2. Executive Summary3. Introduction4. Large Volume Wearable Injectors: Current Market Landscape5. Product Competitiveness Analysis6. Large Volume Wearable Injectors: Key Players7. Drug-Device Combinations: Tabulated Profiles8. Partnerships and Collaborations9. Key Acquisition Targets10. Patent Analysis11. Large Volume Wearable Injectors: Likely Drug Candidates12. Emerging Trends on Social Media13. Clinical Trial Analysis14. Case Study: Role of CMOs in Device Development Supply Chain15. Regulatory and Reimbursement Landscape for Medical Devices16. Market Sizing and Opportunity Analysis17. SWOT Analysis18. Executive Insights

Companies Mentioned

For more information about this report visit https://www.researchandmarkets.com/r/p6d8mi

Research and Markets also offers Custom Research services providing focused, comprehensive and tailored research.

Go here to read the rest:

Global Large Volume Wearable Injectors Market Outlook to 2030 with Competitive Analysis on 400+ Players - GlobeNewswire

Oxford Universitys Covid-19 vaccine candidate, AZD-1222, proved to be safe and effective with few side effects, preliminary trial results showed on Monday. According to pharmaceutical company AstraZeneca, they have finalised a license agreement with Oxford University for the vaccine candidate.

Earlier this week, the BBC initially reported that the UK government has already ordered 100 million doses of the Oxford vaccine, and later added that the government signed deals for an additional 90 million doses of the other promising BioNtech/Pfizer and Valneva vaccines. (These two vaccines are being researched by an alliance between the pharmaceutical companies BioNtech and Pfizer, as well as the firm Valneva.)

AstraZeneca, however, doesnt have any direct involvement with South Africas vaccine trial as the agreement to do the trial here preceded Oxfords agreement with AstraZeneca for further clinical development and manufacturing of the vaccine, said Shabir Madhi, Professor of Vaccinology at the University of the Witwatersrand (Wits) in Johannesburg, during an ECN (Economist Corporate Network) Africa webinar today. Madhi is leading the SA trial.

Many other countries in similar situation

South Africas Covid-19 vaccine trial is being funded by the South African Medical Research Council (SAMRC) and the Bill and Melinda Gates Foundation. At the moment, there is no agreement with AstraZeneca to prioritise access to the vaccine for South Africa, should it prove successful. But this wouldnt be unique to South Africa, said Madhi.

Many other countries are in a similar situation. I think for low-to-middle income countries, including South Africa, the best opportunity to gain access at an early stage (once the vaccines do become available) is through the initiative that is being led by CEPI (the Coalition for Epidemic Preparedness) and Gavi.

Unfortunately we [South Africa] are not in the luxurious position of being able to have billions of doses become available in the next twelve months. Theres going to need to be some kind of prioritisation in terms of whos targeted for vaccines, as well as which countries gain access to the vaccines at an early stage, explained Madhi.

The initiative Madhi referred to is known as the COVAX Facility, and according to the World Health Organization (WHO), more than 150 countries are engaged in this global access to the vaccine. The website reads: The COVAX Facility, and the AMC within it, is designed to guarantee rapid, fair and equitable access to Covid-19 vaccines for every country in the world, rich and poor, to make rapid progress towards slowing the pandemic.

AstraZeneca notes that commitments to supply more than two billion doses of the vaccine have so far been agreed withthe UK, US, Europes Inclusive Vaccines Alliance, CEPI, Gavi the Vaccine Alliance, and Serum Institute of India. The company is engaging with these international organisations for the fair allocation and distribution of the vaccine worldwide.

South Africa, fortunately, has already expressed interest in procuring vaccines through the COVAX mechanism, added Madhi.

Late-stage Phase II/III trials of the vaccine are currently underway in the UK, Brazil and South Africa and are due to start in the US. AstraZeneca also stated in a media release this week that they will continue to fulfil their commitment for broad and equitable access to the vaccine, should these late-stage clinical trials prove successful.

Smart choice to order millions of doses?

Based on the UKs decision to order 190 million doses of the promising vaccines, we chatted to two local experts on whether this is a wise move.

Professor Thomas Scriba, Deputy Director of Immunology and Laboratory Director at UCT, explained that although there is some risk involved in ordering doses for a vaccine that we dont yet know for certain works, the UK is simply trying to ensure that they get an allocation, considering the excessive demands for this vaccine should it turn out to be effective.

I guess because theyre developing it, theyre trying to get in their order to be first in line, said Scriba. This, of course, borders on the topic of 'vaccine nationalism'.

Scriba explained: In an ideal world, it should be equitable and everyone should have access to health products that can save lives and reduce morbidity and mortality. Of course, this is not an ideal world and what often happens is that certain governments and institutions invest a lot of effort and money into the development of these products, making them positioned to have more say about negotiating access to it.

I think its really important that theres strong advocacy for making it equitable around the globe, and one of the things that we can do in South Africa, for example, which will help to negotiate access to new products, is to take part in these clinical trials.

"If we are part of the international effort that develops interventions for Covid-19 (or for any other type of disease), then it also puts us in a position to negotiate access to the vaccine," said Scriba: Theres actually an ethical obligation if South African participants take part in trials, in that they took some risk, and that risk should be offset by the agreement that they would then get access to the product, should it prove to be efficacious.

Nonetheless, Scriba concluded that it potentially puts other countries which may not be in a position to participate in such trials at a disadvantage.

Its a very difficult situation, and as I said, ideally, access should be equal but, unfortunately, theres not going to be enough vaccine for all countries, especially at the beginning."

To navigate this tricky space, there will have to be some system to select who gets the vaccine and who doesnt, said Scriba.

Onus on investigators of trials to negotiate access

Honorary Professor Robert Wilkinson from the Institute of Infectious Disease and Molecular Medicine (IDM) at the University of Cape Town (UCT), and Director of The Wellcome Centre for Infectious Diseases Research in Africa (CIDRI-Africa) echoed Scribas sentiments above, saying that if you take the risk, then you should get the benefit, and further commented that the investigators (scientists) running the trials must ensure negotiation of access to the product as part of their agreement to do the trial.

I think thats an ethical necessity. When you agree to do the trial, I think its ethically important to have negotiated potential access to the product in the event that efficacy is demonstrated.

We need to guard against a nationalist approach

Touching on the above topic of vaccine access, Madhi commented during the webinar that for most low-to-middle income countries who dont have the financial power of the US or the UK, for example, the COVAX Facility is likely the best opportunity to gain access to vaccines at an affordable price and at an early stage, said Madhi, who further cautioned against a nationalist approach.

We have been engaging locally with AstraZeneca to see what might be possible for South Africa, in terms of gaining early access, but, again, procuring it through the COVAX mechanism is our best opportunity.

Even as South Africans, we need to guard against a nationalist approach. Even if a vaccine is shown to be effective here, we cant exactly do what the US is doing right now, in insisting that because the vaccine is being developed there, they need to get priority access. I think the COVAX mechanism is a model of greater equity concerning distribution of the limited supply vaccine that will be available."

Madhi also explained that the model is an advanced market commitment to the procurement of vaccines from different manufacturers, and that middle-income countries would be able to source vaccines from the bulk that is procured, and at a cost which is extremely favourable. Low-income countries, he added, will probably have vaccines donated to them through the same mechanism.

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Covid-19 vaccine trial in SA: Will we have access to treatment if it is a success, and approved? - Health24

Breast Imaging Market by Technology [Mammography (FFDM, Digital & 3D Mammography), Breast Ultrasound, MRI, CBCT, MBI, PET-CT, ABUS, Optical Imaging], End user (Hospitals & Clinics, Breast Care Centers, Diagnostic Imaging Centers) -Global Forecasts to 2025

Market growth is largely driven by factors such as technological advancements, the rising prevalence of breast cancer, the increasing number of screening programsas well as rising number of conferences and symposiums focusing on spreading awareness about the benefits of early screening and diagnosis. The emerging markets, growing government and private investments to meet the increasing demand for breast cancer screening, and the improving reimbursement scenario are expected to present a wide range of growth opportunities for market players.

According MarketsandMarkets Research Report [215 Pages Report] The breast imaging market is projected to grow from an estimated USD 3.7billion in 2020 to USD 5.4 billion by 2025, at a CAGR of 8.1% during the forecast period.

Breast Imaging Market and Emerging Technologies:

Download PDF Brochure:www.marketsandmarkets.com/pdfdownasp?id=897

Breast Imaging Market and Key End-users:

Key End-user industries for breast imaging products are:

Report: http://www.marketsandmarkets.com/requestasp?id=897

Breast Imaging Market and Top Companies

Key market players profiled in the breast imaging market report includes:

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Breast Cancer Screening and Diagnosis Growth in Breast Imaging Technologies Market scrutinized in the new analysis - WhaTech Technology and Markets...