There Is Little Evidence That Mass Transit Poses a Risk of Coronavirus Outbreaks – Scientific American

In the early months of the COVID-19 pandemic, Ben Fried made a difficult decision: He stopped riding New York Citys subway system.

He was not alone. Ridership on the citys notoriously packed commuter trainsdropped92% in mid-April, when New York emerged as an epicenter of the global health crisis.

For Fried, the decision was especially tough because he serves as communications director for TransitCenter, an advocacy group that touts the environmental benefits of mass transit.

But as the virus spread, those benefits were overshadowed by the risk of contagion in the enclosed spaces of subway cars.

I think the prevailing attitude then was, If you dont need to ride, dont ride, Fried recalled in a recent phone interview.

Since those first fateful months, however, Fried has ventured back onto the subway with his wife. And hes become part of a vocal group of advocates saying the initial fears of mass transit were overblown.

Those advocates say there is scant evidence tying major coronavirus outbreaks to buses and trains. On the contrary, they say, transit can play a crucial role in the pandemic era by reducing air pollution that makes people more susceptible to COVID-19.

Two prominent proponents of this argument are Janette Sadik-Khan, the former commissioner of the New York City Department of Transportation, and Seth Solomonow, the co-author of Streetfight: Handbook for an Urban Revolution.

In a recentopinion pieceinThe Atlantictitled Fear of Public Transit Got Ahead of the Evidence, the pair wrote that many have blamed subways and buses for coronavirus outbreaks, but a growing body of research suggests otherwise.

The piece noted that epidemiologists use the term cluster to describe major coronavirus outbreaks. A cluster is defined as more than three cases that can be traced to a common event or venue, excluding transmission within households.

In Paris, a recentstudyfound that none of the citys 150 coronavirus clusters from early May to early June originated on the citys transit systems,Le Parisiennewspaperreported.

The study was conducted by researchers at Sant Publique France, the national public health agency. It was published June 4.

As of July 15, four transport clusters had been identified in Paris, accounting for roughly 1% of 386 total clusters, according to data from the agency.

Its a similar situation in Japan, where researchers failed to connect a single cluster to the countrys commuter trains, said Hitoshi Oshitani, a virologist and public health expert at Tohoku University.

The vast majority of the clusters were instead traced to gyms, bars, live music venues, karaoke rooms and similar establishments where people come in close contact with one another, Oshitani said in an email to E&E News.

The evidence is less robust in the United States, which lags other developed countries in contact tracing and coronavirus testing.

Contact tracing involves determining an infected persons close contacts, which the Centers for Disease Control and Preventiondefinesas any individual within six feet of an infected person for at least 15 minutes.

Epidemiologists interviewed for this story couldnt point to comparable research on contact tracing that focused on U.S. transit systems.

The epidemiologists also were unsure whether riding transit in America was riskier than other activities amid the pandemic, such as going to the gym or eating at a restaurant with outdoor seating.

How risky is it? Well, theres nothing in life that doesnt have risk. And in the COVID era, everybody is trying to assess what risks theyre willing to take, said Ruth Collins, associate professor of molecular medicine at Cornell University.

Its difficult to classify the danger of any activity during the pandemic given the lack of robust data, Collins said. But in general, she noted, riding transit is much safer if all passengers are wearing face masks that cover their noses and mouths.

Melissa Perry, a leading epidemiologist and chair of the Department of Environmental and Occupational Health at George Washington Universitys Milken Institute School of Public Health, agreed with this assessment.

When you have universal adherence and compliance with mask use, thats when you are majorly reducing the risk for transmitting the virus, Perry said.

Both mask wearing and physical distancingor keeping 6 feet apart from fellow passengersare the most important considerations, she said. They take precedence over cleaning and disinfecting surfaces, which are much less likely to spread the coronavirus than respiratory droplets, according to the CDC.

Still, transit poses the risk of high-touch surfaces such as handrails and elevator buttons that a lot of people have touched before you, Perry said.

Not all surfaces are created equal, she said. With the standard surfacelets say you pick up an item in the grocery store or get a box in the mailthe likelihood of getting COVID-19 is very low. With public transportation, what were talking about is high-touch surfaces. And those are higher-risk surfaces.

Regardless of its relative safety, transit can play a crucial role in combating climate change and air pollution, advocates said.

Public transportation produces far less greenhouse gas emissions per mile than cars, according tofindingsreleased by the Department of Transportation under President Obama. Leading the pack are subways, which boast 76% less carbon emissions than the average vehicle carrying a single person.

In addition to planet-warming pollution, transit also produces fewer criteria air pollutants such as particulate matter and nitrogen dioxide.

Recent research from Harvard University, which has not yet been peer-reviewed, found a tentative link between higher exposure to particulate matter and higher mortality rates from COVID-19, particularly among communities of color (Greenwire, April 7).

Shared transportation is so critical to keeping cities congestion-free. And congestion exacerbates the air quality issues that are such a huge part of the calculus of the public health crisis now, said Brianne Eby, a senior policy analyst at the Eno Center for Transportation, a Washington-based think tank.

Fried, the communications director for TransitCenter, agreed.

If everyone who has a car starts to drive instead of taking the train or the bus, then particulate emissions are going to rise, and thats going to exacerbate a lot of the health disparities that have hit communities of color especially hard during COVID, Fried said.

And then theres the long-term climate risk associated with rising carbon emissions, he added. So if we see a big shift from transit to driving, thats going to put climate goals out of reach.

Reprinted from Climatewire with permission from E&E News. E&E provides daily coverage of essential energy and environmental news atwww.eenews.net.

Editors Note (7/30/20): Our partners at Climatewire have edited thisstoryafter posting to correct the sourceof information on the transport clusters identified in July 15 and to remove a comment regarding the June 4 study.

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There Is Little Evidence That Mass Transit Poses a Risk of Coronavirus Outbreaks - Scientific American

Delivering on the promise of precision cancer medicine and why it matters even more during a pandemic – MedCity News

While many of us have avoided exposure to Covid-19 by sheltering in place, patients with advanced cancer have faced difficult choices about moving ahead with immune-compromising, but potentially life-saving treatments, and leaving the safety of their homes to receive infusions at hospitals or treatment centers.

Even more challenging, for many patients, the pandemic has altered the landscape of practically available treatment options. The best treatment for many patients with advanced cancer is often available only through a clinical trial. Trials traditionally have taken place at leading academic medical centers, which means patients often must travel long distances to participate and receive novel treatment.

Precision medicine has always been about getting the right drug to the right patient at the right time. I would argue not only do we in the oncology community need to embrace the promise of precision medicine more fully but also that the definition should be expanded to, the right drug to the right patient at the right time and in the right place. We need to make promising treatments, including the latest clinical trials, available locally.

Advancing Precision Medicine through Tumor Molecular ProfilingComprehensive tumor molecular profiling is foundational to precision medicine. While patients may have the same cancer type, variations within individual genomes may determine how well one patient responds to a certain treatment compared to another. Oncologists must have access to actionable molecular information to select the right treatment for their patients.

Since the human genome was mapped for the first time in 2003, a number of technological and scientific advances have made it possible for patients with cancer to receive comprehensive tumor molecular profiling results in less than two weeks, with costs increasingly covered by payers. Biomarkers are now widely used to identify patients for treatment with a specific therapeutic agent. Increasingly, cancer therapies are developed in tissue-agnostic indications, meaning they are approved based on molecular changes rather than the site of tumor. In June of this year, the U.S. Food and Drug Administration approved pembroluzumab (Keytruda) for the treatment of any solid tumor that is tumor mutational burden (TMB) high.

With these advances, one would think that every patient with advanced disease would receive tumor molecular profiling as a standard of care. However, this is not the case. Only about 15% of patients with advanced cancer receive comprehensive tumor profiling. Widespread deployment of tumor molecular profiling is emerging as a rate-limiting factor for how rapidly we can drive better outcomes for all patients with cancer.

Practical Challenges to Widespread Precision Oncology AccessWhy are patients not able to fully benefit from the promise of precision medicine? There are a several key barriers to access, including:

Addressing the ChallengeHow precision medicine companies, providers and health systems work together to develop and deploy solutions will determine how successfully we can deliver on the promise of precision cancer care. Some precision medicine companies are developing blood tests, called liquid biopsies, that identify potential tumor cells circulating in the blood with the goal of reducing reliance on tumor tissue biopsies. Others are undertaking educational campaigns to encourage broader uptake of comprehensive genomic testing. And there are companies that deliver a comprehensive precision oncology program to health systems, providing widespread and routine access to comprehensive tumor molecular profiling paired with local access to a portfolio of biomarker-guided clinical trials. A study presented by Kaiser Permanente Northern California at the 2020 ASCO meeting demonstrated how industry partnerships can enable health systems to implement and deliver a large-scale comprehensive precision oncology program.

Knowing which treatment is right can mitigate risk in unexpected ways as well. In a recent anecdote from our lab, tumor tissue from a 70-year old patient with advanced non-small-cell lung cancer was sequenced and found to have a rare, but highly actionable, gene fusion that could be treated with an orally available targeted therapy. Instead of having to attend multiple infusion visits for chemotherapy and immunotherapy that would result in substantial exposure risk to Covid-19, the patient can now receive a targeted therapy that can be taken at home with an expected dramatic response.

A Better FutureThis pandemic has taken a toll on everyone, and patients with advanced cancer have faced unique challenges. However, the opportunity before us is one to create the future we should all be working toward: a future where the right patient receives the right treatment, at the right time and in the right place. As we continue to work our way through this current pandemic, lets envision a future where every patient with cancer has access to the latest in precision medicine by implementing broad-scale genomic testing and democratizing access to clinical trials so that whatever environment we face, cancer patients will always receive the best care.

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Delivering on the promise of precision cancer medicine and why it matters even more during a pandemic - MedCity News

mTOR and the Science of Aging and Chronic Disease – The Doctor Weighs In

What if you could age slower and maintain your ability to be active and enjoy your family well into your 70s or 80s or beyond? What if you could delay the onset of chronic disease by almost a decade? Well, that is no longer a dream. Thanks to advances in the science of aging and chronic disease, we know that there are things that you can do now to impact your health and, perhaps, your longevity.

Lets start our discussion by diving into some of the basic science related to prolongation of a healthy lifespan. Dont worry, we are going to start with a video and its going to be fun.

First, check out this very entertaining short TED talk by Cynthia Kenyon who is a top scientist at the University of California at San Francisco Medical School. Then come back to this post for an expanded discussion.

The importance of Dr. Kenyons work and that of contemporary aging researchers is that they showed, for the first time, that aging and age-related chronic diseases arent things that just happen to us. [1] They are, in fact, related to an evolutionarily-conserved complex, highly regulated, and interconnected series of biochemical pathways.

Central to these pathways is a molecule called mTOR which stands for mechanistic Target of Rapamycin. It is so-named because rapamycin, a naturally occurring substance, inhibits the many of the activities of mTOR triggering a variety of metabolic and clinical outcomes. The most well-known of which is the extension of healthy lifespan.[2, 3]

mTOR exists as a complex of proteins called mTOR complex or mTORC. There are actually two different forms mTORC known as mTORC1 and mTORC2. Activation of the complexes occurs via different pathways. Once activated the mTOR complexes, in turn, activate or inhibit pathways critical to cell function. [2, 3]

mTORC1 and 2 are activated or inactivated depending on the availability of nutrients in the cells environment (e.g., glucose, amino acids and various growth factors). In fact, you can think of mTORC as integrating and responding to the energy status of the cells environment.

When times are good and energy, oxygen, nutrients, and growth factors is plentiful, mTORC1 is activated and stimulates metabolic pathways that lead to growth. When times are tough, those pathways are suppressed and the pathways related to survival are activated.

Here are some of the cellular functions mTORC1 regulates [2,4]:

The last two functions are inhibited when energy, nutrients, and growth factors are plentiful.

mTORC2 is activated by insulin and growth factors. [2,4] It regulates the following:

Rapamycin inhibits most but not all of the activities of mTORC1. However, it does not inhibit mTORC2 in the short run. There is some evidence that chronic administration of rapamycin, however, can inhibit mTORC2.[4] Further, there are important feedback pathways between mTORC1 and mTORC2.

Living organisms on our planet are subject to varying availability of nutrients and other sources of energy. In order to survive, they must be able to sample the energy availability in their surroundings and adjust accordingly.

mTOR-linked pathways provide that mechanism. Receptors found in cell membranes have both an external-facing component and an internal-facing component. The external component binds to nutrients, such as glucose, amino acids, oxygen, and various growth factors. As described above, this leads to the activation or inactivation of different intermediate proteins that ultimately activate or inhibit mTOR.

For example, during times of energetic stress, a protein known as AMPK is activated. This in turn inhibits mTORC1 and leads to activation or inhibition of other intermediate compounds. The result is a state of cellular activity that favors prolongation of lifespan.[5]

Although the pathways are incompletely understood, it is of note that dietary restriction a self-induced famine in a way is also associated with longevity.[5] We must remember, though, because of complex feedback loops, the ability to prolong lifespan via these mechanisms is not limitless.

On the other hand, during times of plenty, the availability of glucose increases. In addition to reducing the activation of AMPK, it also triggers the release of the hormone insulin and insulin-like growth factor). This leads to mTOR activation and creation of a state that favors growth and development including such things as elevated lipid levels that favor the development of chronic diseases.

Understanding the molecular biology of the mTOR pathways has some very practical applications. For example, as we have already pointed out, restricting calories is associated with reduced levels of some factors that inhibit mTORC1 and is associated with lifespan extension.[5] Intermittent fastingand exercise also reduce mTOR activity.

Also, restricting carbohydrates in people with Type 2 diabetes is known to lower blood glucose, insulin, and IGF-1 levels. The benefits of this type of diet does not require weight loss, although many do lose weight with carbohydrate restriction. [6] In fact, some experts have called for dietary carbohydrate restriction to be the first intervention prescribed in diabetes management. [6]

The prevailing American high-carbohydrate, high-fat fast-food diet, on the other hand, drives extra calorie intake and as well as higher levels of the factors that activate mTORC1. This, unfortunately, leads to metabolic conditions that accelerate the development of chronic diseases such as diabetes and heart artery problems.[6]

Metformin is the most commonly prescribed drug for Type 2 diabetes. It interferes with the same signaling pathways that we have been discussing. Specifically, it leads to the reduction of glucose, IGF-1, insulin levels. This, in turn, leads to inhibition of mTORC1. This results in a metabolic state that favors important health outcomes, such as:

Further, the drug has been proven to be safe with relatively few serious side effects. And, it is cheap, making it accessible even for people without health insurance.

Metformin is the also first drug approved by the FDA to enter a clinical trial to assess its effect on prolongation of a healthy lifespan. According to American Association for Aging Research, the Targeting Aging with Metformin (TAME) trials are a series of nationwide, six-year clinical trials at 14 leading research institutions across the country that will engage over 3,000 individuals between the ages of 65-79.

These trials will test whether those taking metformin experience delayed development or progression of age-related chronic diseasessuch as heart disease, cancer, and dementia.

As mentioned, the drug rapamycin inhibits mTORC1 activity and is associated with a prolonged lifespan. However, systemic rapamycin has unacceptable side effects, so its use is limited in humans.

It is used, however, for local applications. One example is the use of Sirolimus (the brand name of rapamycin) in early versions of drug-eluting stents (DES) used to treat coronary artery disease. [7]

More recently, scientists have modified rapamycin to create less toxic forms of the drug. They are known as rapalogs. These include everolimus, zotarolimus, and biolimus. Together with improved stent platform materials, the use of these DESs have been shown to lower thrombotic events related to the stents. [8]

There are a number of drugs that are used for cardiovascular disease that specifically impact the mTORC pathways by various mechanisms. For example, lisinopril (ACE inhibitor), losartan (angiotensin receptor blocker), atorvastatin (statin), and eplerenone (mineralocorticoid receptor blocker) all reduce oxidative particle formation. Indirectly, this lead to the inhibition of mTORC.

This, as we know, leads to metabolic changes that favor healthy aging. These effects on the mTOR-related signaling pathways may be the reason why these medications lower the risk of heart attack and stroke more than they reduce the target risk factors of blood pressure, lipid, and glucose levels.

On the other hand, tobacco smoke increases oxidative stress and favors the activation of mTORC pathways. This may eventually lead to Chronic Obstructive Lung Disease (COPD) and lung cancer.

Interfering with this core signaling is a form of precision medicine that impacts the molecular biology that causes cardiovascular disease, cancer, and accelerated aging. These medications are antioxidants that work.

Here is the most shocking insight. The same core signaling that causes accelerated aging, chronic disease, and ultimately death is essential to produce a perfectly developed newborn. At the moment of conception, there is a single cell that will ultimately become all the cells in the body with their vastly different functions.

The DNA for every cell in your body is the same. Epigenetic regulation determines which genes are turned on or off in a particular cell type. For example, normal EGFR function is necessary to establish pregnancy successfully at the very beginning of life. However, it contributes to chronic disease development later.

Angiotensin II is required to form a normal fetal kidney, but inappropriate activation later in life contributes to developing hypertension, chronic kidney disease, and congestive heart failure.

mTOR activation via nutrient sensing and growth factor signaling in the fetus directs a master symphony of switching genes on in just the right place, at just the right time, with just the right intensity for an exact amount of time to produce a perfect infant.

However, the same genes that are essential to coordinate normal development cause disease and death with chaotic activation later.

The human genome project did not give us the answers for accelerated aging and common chronic diseases. These problems are caused by normal genes that are inappropriately switched on later in life by things like aging, unhealthy diets, and tobacco smoke.

Specific highly effective generic medications with few side effects can block the signaling from those genes and lead to dramatically better clinical outcomes at a lower cost. Caloric restriction, intermittent fasting, exercise, and the specific medications mentioned all impact the same signaling.

New science, new systems, and new payment models can improve our health at a lower cost. All the necessary elements are available. It is time to bring the stakeholders together and get started.

2. Papadopoli D, Boulay K, Kazak L, et al. mTOR as a central regulator of lifespan and aging [version 1; peer-review: 3 approved] latest versions as of 07/27/20. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6611156/pdf/f1000research-8-18802.pdf

3. Weichhart T. mTOR as regulator of lifespan, aging and cellular senescence. Gerontology. (2018) 64(2):127-134.https://pubmed.ncbi.nlm.nih.gov/29190625/

4. Samidurai A, Kukreja R, Das A. Emerging role of mTOR signaling-related miRNAs in cardiovascular diseases. Oxidative Medicine and Cellular Longevity. Volume 2018, Article II6141902, 23 pages https://www.hindawi.com/journals/omcl/2018/6141902/

5. Longo V, Antebi A, Bartke A, et al. Interventions to Slow Aging in Humans: Are We Ready? Aging Cell (2015) 14, 497-510. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4531065/

6. Feinman R, Pogozelski W, Astrup, A, et al. Dietary carbohydrate restriction as the f first approach in diabetes management: Critical review and evidence base. Nutrition(2015) 31:1-13.https://www.sciencedirect.com/science/article/pii/S0899900714003323

7. Serruys P, Regar E, Carter A. Rapamycin eluting stent: the onset of a new era in interventional cardiology.Heart(2002) 87:305-305.https://www.researchgate.net/publication/277539488_Rapamycin_eluting_stent_the_onset_of_a_new_era_in_interventional_cardiology

8. Im E, Hong, M-K. Drug-eluting stents to prevent stent thrombosis and restenosis (2016) 14(1):87-104 https://pubmed.ncbi.nlm.nih.gov/26567863/

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mTOR and the Science of Aging and Chronic Disease - The Doctor Weighs In

A breakthrough: Stem cell therapy cures Covid-19 The Manila Times – The Manila Times

SIX patients who were suffering from the acute coronavirus disease 2019 (Covid-19) were cured through the stem cell technology using blood from preserved umbilical cords.

The revolutionary method of curing the dreaded virus, which originated in China and has spread worldwide, was announced by The Medical City (TMC) hospital in Pasig City.

Health Secretary Francisco Duque 3rd was informed of the breakthrough in treating the pandemic illness through a letter sent by Dr. Eugenio F. Ramos, TMC president and chief executive officer, on Thursday, July 23.

Our government, particularly the Department of Health, can take pride in the fact that the Philippines is not behind at all in innovative practice in medicine, said Ramos in his letter to Duque.

The TMC has been experimenting with stem cell therapy since 2015 through its Institute of Personalized Molecular Medicines stem cell program.

The stem cell experiment was made on seven Covid-19 patients who were so ill they were about to be intubated.

Intubation means inserting a tube into the patients mouth that reaches the trachea to allow him/her to breathe through a lung machine.

Six of the seven patients had recovered, the TMC said; one was so ill he died during the procedure.

As I told you this morning, we would have wanted to complete at least 10 Covid-19 cases before informing you, but it might be taken against us if we kept this knowledge from the public too long while patients are dying and no single drug seems to work, Dr. Ramos told Duque.

Ramos simplified for the public how the stem cell therapy works:

Stem cells are very young cells from the body that can be differentiated into whatever cell lines (lung, heart, kidney, liver, skin, etc.) that the body needs when it needs them, e.g., when an organ is injured or deteriorates. Stem cells can be triggered or infused to do [repair] work.

In severe Covid-19 cases, what triggers a cascade of inflammatory cells (called cytokines) is the injury caused by the virus. The lungs, in particular, become inflamed and the respiratory function rapidly deteriorates leading to death.

Before the cascade happens in which case the patient is in a severe condition probably requiring intubation the infusion of mesenchymal stem cells collected [from] the umbilical cord and grown in [the regenerative medicine laboratory of TMC into the patients veins, takes place.

A total of four infusions are given over a short period of a few days. These messenchymal stem cells rally the cells in the lungs to fight the cytokines.

In short, the stem cells from the umbilical cord produce new cells to replace those damaged by the virus in the lungs, leading to the patients recovery.

The umbilical cord is rich in nutrients to rebuild destroyed tissues, according to Ramos.

TMCs stem cell program also makes use of bone marrow taken from a patients spine to cure cancer.

But the bone marrow stem cell is also used to delay the aging process in elderly patients.

TMC had the most number of bone marrow transplantation for blood cancers, with more than 90 percent survival rate, said Dr. Ramos.

Since 2015, a total of 112 patients have enrolled in TMCs regenerative medicine program.

Of the total, 57 percent were cancer patients and 43 percent were non-cancer patients, said TMCs Dr. Michelle Joy Baldorado-de Vera.

Oncologists (doctors who specialize in cancer) are part of the regenerative medicine program Alan Olavere, Marina Chua-Tan and Josephine Tolentino.

Other members are hematologists (blood doctors) Norma Ona and Alma Calavera, neurologists John Tiongson and Marc Joseph Buensalido, and immunologist Michelle de Vera.

Dr. Sam Bernal, a Filipino American who grew up in the United States, is a consultant to the program.

Bernal is a molecular scientist and an oncologist who has been into stem cell technology for decades.

He was part of the foreign group that was tapped by the government for technology transfer.

Former Health secretary Alfredo Bengzon, who is a part owner of TMC, engaged Bernal to pioneer stem cell therapy in the country.

TMC has had foreign patients who underwent stem cell therapy, but refuses to disclose their number.

As is the norm among Filipinos who have the crab mentality, TMCs stem cell program has been criticized by fellow doctors.

Weve been defending the program from the outset, said Dr. Ramos.

But its not only TMC that has been into stem cell therapy; the other hospitals are the Makati Medical Center and the governments National Kidney and Transplant Institute.

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A breakthrough: Stem cell therapy cures Covid-19 The Manila Times - The Manila Times

A shift in brain glucose metabolism may help explain women’s increased risk of Alzheimer’s disease – National Institute on Aging

In the United States, two-thirds of Alzheimers disease diagnoses are in women. While its well-established there are indeed sex differences in the risk and prevalence of Alzheimers, scientists are unsure about why women are more likely to get this disease. Even when taking womens average longer lifespans into account, the increased risk remains, indicating that biological sex differences influence how the disease begins and spreads.

To increase understanding, an NIA scientific team used data and samples from participants in the Baltimore Longitudinal Study of Aging (BLSA) along with animal and human cell models to zero in on sex-based differences in how the brain metabolizes sugar as a culprit and potential therapeutic target. Their findings were published the journal Acta Neuropathologica.

Prior studies have shown that women with Alzheimers carry higher levels of amyloid plaques and neurofibrillary tangles than male counterparts. Women also have more severe cognitive symptoms compared to men at the same disease stages. Based on previous work in the field, the NIA team knew that changes in brain glucose metabolism are seen decades before cognitive impairment becomes obvious. They focused on a cross-species approach to further investigate why problems metabolizing glucose (sugars) may be a prelude to dementia-like symptoms. To compare metabolic activity, they analyzed brain tissue and blood samples from BLSA participants who had Alzheimers, along with lab-grown human cell models of Alzheimers, two Alzheimers mouse models, and two specialized strains of flatworms.

The scientists observed that Alzheimers caused impairment in the mitochondria (cell powerhouses") of brain synapses junctions for chemical or electrical signals between neurons in female, but not male, mice. Next, the mouse and human cell models consistently showed that the brain and body try to adapt to this metabolic impairment by shifting from processing glucose (sugars) to lipids (fatty acids.) The scientists then proved that this metabolic shift is needed for survival in both worms and human cell culture Alzheimers models.

Interestingly, further study of animal models and human cell samples showed that males were better able than females to adapt to this metabolic shift at the molecular level. These significant differences in mitochondrial mechanisms and metabolic responses to Alzheimers may explain why there are sex-related differences in risk and disease development.

This study also identified specific molecular and metabolic impairment sites and pathways in mice and humans that are likely connected to sex differences. Further research is needed to develop precision medicine targets for interventions.

This research was funded in part by NIA grant ZIA AG00073817 and the NIA Intramural Research Program.

Reference: Demarest TG, et al. Biological sex and DNA repair deficiency drive Alzheimer's disease via systemic metabolic remodeling and brain mitochondrial dysfunction. Acta Neuropathologica. 2020;140(1):25-47. doi: 10.1007/s00401-020-02152-8.

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A shift in brain glucose metabolism may help explain women's increased risk of Alzheimer's disease - National Institute on Aging

Global Bioinformatics Service Market Report COVID-19 Outbreak Development Trends, Threats, Growth Opportunities and Competitive Landscape in 2024 -…

Global Bioinformatics Service Market presents comprehensive insights into the present and upcoming industry trends, enabling the readers to identify the products and services, hence driving the revenue increase and effectiveness. The research report presents a complete breakdown of all the major factors affecting the market on a global and regional scale, including drivers, constraints, threats, challenges, opportunities, and Bioinformatics Service industry-specific trends. Further, the report mentions global facts and figures along with downstream and upstream analysis of leading players.

The study gives answers to the following key questions:

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Major Players:

Agilent TechnologiesQIAGENCD GenomicsThermo Fisher ScientificIlluminaStrand Life SciencesBGI GroupDNANEXUSBiomax InformaticsGene CodesCreative-BiolabsFIOS GenomicsGene CodeDNASTARBiomatters GeneiousPerkinElmerGSL Biotech LLC (SnapGene)Premier Biosoft

This research presents Bioinformatics Service market growth rates and the market value based on market dynamics, growth factors. The complete knowledge is based on the newest innovation in the business, opportunities, and trends. In adding up to SWOT analysis by key suppliers, the report contains an all-inclusive market analysis and major players landscape.

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The regional segmentation covers:

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Global Bioinformatics Service Market Size, Status and Forecast 2020-2024

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Global Bioinformatics Service Market Report COVID-19 Outbreak Development Trends, Threats, Growth Opportunities and Competitive Landscape in 2024 -...

Photopharmacology Switching Drugs On and Off With Light – Technology Networks

Light and medicine have a long and intertwined past. Most civilizations throughout history appear to have understood that there was a connection between sunlight and good health. The ancient Egyptians worshipped the sun, with Ra the sun god often described as the king of all gods. Both the ancient Romans and Greeks used sunbaths to maintain good health. Heliotherapy (helio is Greek for sun) was deemed an important part of athletic training in ancient Greece as it was thought to improve muscle health.The link between light and medicine was exemplified by Niels Finsen a pioneer of modern phototherapy. Finsen was awarded the 1903 Nobel Prize in Physiology or Medicine in recognition of his contribution to the treatment of diseases, especially lupus vulgaris, with concentrated light radiation, whereby he has opened a new avenue for medical science.

By the end of the first quarter of the 20th century, the use of phototherapy for medical purposes, in northern Europe and some regions of North America, was considerable. Prof. Dirk Trauner says that whist phototherapy has been hugely successful, the chemistry that currently mediates the effects of light in phototherapy is relatively simple.

Trauner and his team set out to develop more sophisticated ways to harness light therapeutically. We have been joined in this effort by a growing number of colleagues, explains Trauner. Ben L. Feringa is one such colleague, who was jointly awarded the Nobel Prize in Chemistry for the design and synthesis of molecular machines in 2016.

Trauners work is based photopharmacology, an innovative approach whereby light is used to activate and deactivate therapeutics and/or biological processes.

However, by introducing photopharmacology, Trauner explains that it is possible to add a further level of control to the PROTAC. One can target their [PROTACS] action to specific tissues or tumors, avoiding side effects elsewhere in the body, says Trauner.

Whilst phototherapy is typically applied to the surface of the skin, PHOTACs could be switched on and off within the body by means of an endoscope combined with a light source, or by using an implanted LED.

Furthermore, in future, by using different colors of light a concept known as color dosing it could be possible to control the activity of PHOTAC-based therapeutics even more precisely. By regulating the concentration of the active or switched-on form of the PHOTAC, dosage of the drug could be altered within the body gradually.

PHOTACs do work like PROTACS but can be activated or inactivated at will as long as light-delivery is possible. Light-delivery in the human body has become quite sophisticated in recent years. New technologies for light delivery are emerging, largely driven by optogenetics and photodynamic therapy, concludes Trauner.

Reference: Reynders, et al. (2020). PHOTACs enable optical control of protein degradation. Science Advances. DOI: 10.1126/sciadv.aay5064Dirk Trauner was speaking with Laura Elizabeth Lansdowne, Senior Science Writer for Technology Networks.

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Photopharmacology Switching Drugs On and Off With Light - Technology Networks

How AI is uncovering the ‘dark matter of nutrition’ – World Economic Forum

The COVID-19 pandemic didnt just transform how we work and communicate. It also accelerated the need for more proactive health measures for chronic health problems tied to diet. Such problems have emerged as a top risk factor for coronavirus and people with poor metabolic health accounted for half of COVID-19 hospitalizations in some regions around the world. The resulting high numbers led the authors of a report in The Lancet to issue a call for more resources to tackle metabolic health to avoid needless deaths.

Thankfully, new tools have been developed to offer comprehensive understanding of nutrition. This expertise and technology wont just help us tackle metabolic health it could help us finally fully realize the power of plants to improve health and wellness outcomes.

The first global pandemic in more than 100 years, COVID-19 has spread throughout the world at an unprecedented speed. At the time of writing, 4.5 million cases have been confirmed and more than 300,000 people have died due to the virus.

As countries seek to recover, some of the more long-term economic, business, environmental, societal and technological challenges and opportunities are just beginning to become visible.

To help all stakeholders communities, governments, businesses and individuals understand the emerging risks and follow-on effects generated by the impact of the coronavirus pandemic, the World Economic Forum, in collaboration with Marsh and McLennan and Zurich Insurance Group, has launched its COVID-19 Risks Outlook: A Preliminary Mapping and its Implications - a companion for decision-makers, building on the Forums annual Global Risks Report.

The report reveals that the economic impact of COVID-19 is dominating companies risks perceptions.

Companies are invited to join the Forums work to help manage the identified emerging risks of COVID-19 across industries to shape a better future. Read the full COVID-19 Risks Outlook: A Preliminary Mapping and its Implications report here, and our impact story with further information.

We know that plants are critical for health, but do not fully understand why. Humans have not mapped the breadth of what plants offer, nor have we pinpointed the specific biological mechanisms of action triggered in our bodies when we eat them. This knowledge gap exists at the molecular level, with a need to understand how phytonutrients tiny plant molecules with anti-inflammatory, cardioprotective and neuroprotective properties work in our bodies. In fact, the scientific community refers to the vast world of phytonutrients as the dark matter of nutrition because less than 1% of these molecules have been catalogued to date. The opportunity to learn more about phytonutrients and further tangibly connect their impact to health is massive.

Technologies, such as Artificial Intelligence, are helping researchers learn more about the biological connections between plants and humans. For instance, Brightseed has created a powerful artificial intelligence called Forager, which coupled with advanced metabolomics instrumentation, systematically identifies unknown plant compounds and predicts their likely roles in human health. Thus far, the technology has predicted beneficial phytonutrients for many important health conditions.

Recently, in collaboration with leading biomedical researchers, Brightseed discovered a powerful phytonutrient with the potential to improve metabolic health. This phytonutrient helps restore proper function of a central metabolic regulator, including maintaining healthy lipid and sugar levels in the bloodstream and key organs such as the liver, whose function is impaired by a poor diet. Brightseed will start clinical studies on this phytonutrient before the end of this year.

The impact of this discovery could be wide reaching and have profound implications for more than two billion people worldwide at elevated risk of chronic metabolic diseases. Elevated levels of fat in the liver (which are directly caused by chronic overeating) afflict between 25% and 30% of the global population. These individuals with fatty liver disease are 57% more likely to die prematurely and much more like to develop other debilitating metabolic diseases, including diabetes. The discovery of this phytonutrient is a glimpse into the positive change deeper nutritional understanding could bring.

Just as 1918 pandemic led to creation of the modern medicine industry, we now are at a similar tipping point with nutrition, on the precipice of developing a much more complete understanding of how plants are connected to human health.

The first step is improving our foundational knowledge. In the U.S., there is a broad-based effort among leading academic, non-profit and industry stakeholders to create a National Institute of Nutrition (NIN) to accelerate nutrition science and uncover the role of human nutrition in improving public health and reducing disease. The NIN, similar to institutes that exist in other countries, can support and incentivize higher-quality, more rigorous nutrition research at the molecular level. This research will provide a stronger foundation for nutrition recommendations and guidelines, which is essential to developing consensus in both the scientific and consumer communities.

The second step is a mindset shift. Modern food and agricultural systems have largely focused on - and solved - the problem of food insufficiency. However, preventable diet-driven chronic diseases have emerged instead. We need to pivot from merely increasing the supply of food to leveraging technologies that can help improve the nutritional quality of what we consume.

"We need to pivot from merely increasing the supply of food to leveraging technologies that can help improve the nutritional quality of what we consume."

Healthier food options can be the center of a new proactive health industry and provide the food industry the opportunity to make important contributions to health and longevity, while benefiting economically from the capture of existing healthcare investment that currently is directed to treating chronic disease. Our current treatment-focused healthcare system is increasingly unaffordable and poorly suited to addressing the needs of individuals at heightened risk of developing chronic diseases that are largely preventable through lifestyle modifications, especially those related to diet.

No changes will be possible without forging new collaborations between public and private entities. Through cooperation we can develop more nutritious options and greatly influence policy change. Partnerships are also how well create a more nourished world and maximize our impact.

For the first time, we have the tools to explore the plant kingdom at the molecular level and answer questions such as How does what we eat really affect us? or How can food become medicine?

Technology is exponentially improving our understanding of how plants are connected to health. Together, we can goal shift the healthcare model from one squarely focused on treatment of disease to one that promotes health and natural resilience.

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How AI is uncovering the 'dark matter of nutrition' - World Economic Forum

Spiritual Forces May Be Behind the Difficulties You Face, Yet Cannot Explain – Benzinga

JAMESBURG, N.J., Aug. 1, 2020 /PRNewswire-PRWeb/ -- Author Stanley Beverly seeks to bring hope to the oppressed with The Body of Christ's Need for Bible-Based Deliverance Ministry ($13.49, paperback, 9781631298608; $6.99, e-book, 9781631298615).

Beverly does not seek to offer yet another gimmick or sensational scheme to his readers. Rather, he wants his Bible-based teaching on demonology and spiritual warfare to equip the warriors who are fighting every day, whether they realize it or not.

"My target audience are those who know something is terribly wrong in their [lives], but can't identify it.My target audience are those at the end of their rope, and nobody believes what [is] happening to [them]," said Beverly.

Stanley Beverly was delivered from witchcraft, mentored by Apostle William Brown and ordained by him as an elder in deliverance ministry in 1992. He has also studied under other teachers and pastors to obtain the Holy Spirit's deliverance over the past 22 years.

Xulon Press, a division of Salem Media Group, is the world's largest Christian self-publisher, with more than 15,000 titles published to date. The Body of Christ's Need for Bible-Based Deliverance Ministry is available online through xulonpress.com/bookstore, amazon.com, and barnesandnoble.com.

SOURCE Xulon Press

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Spiritual Forces May Be Behind the Difficulties You Face, Yet Cannot Explain - Benzinga

Finding the road to peace – The New Indian Express

Children, all of us want peace and happiness. Yet, we often face sorrow, frustration and disappointment. Why do we not have peace and happiness? If we want to enjoy peace and happiness, we must first have a correct understanding of life. No matter how much money a rich man has, it will be of no use if he does not even know about his own wealth. Similarly, as long as we are unaware of our true nature, we will not be able to live in harmony with the world and discharge our dharma (duties in life) properly.

A group of travellers were walking to a distant village. After some time, they entered a forest. There was a pond nearby. Putting their belongings down on the bank, they went for a swim. When they returned, they saw that all their belongings were missing. Thieves had stolen everything. The travellers set out at once in hot pursuit of the thieves. On the way, they saw a man resting in the shade of tree; he was a mahatma (spiritually illumined soul). The travellers asked him if he had seen the thieves passing that way.

The mahatma said, Youre upset that your belongings have been stolen. Reflect for a moment. Are the thieves, who are instrumental in robbing your happiness, inside or outside you? Do you want to recover what you lost, or do you want to gain wealth that you can never lose? Think about it!Seeing the wisdom in the mahatmas words, the travellers became his disciples.

There is boundless wealth in each one of us. But because we are not aware of this, we roam around in search of happiness from objects of the world. Some struggle to gain wealth and power whereas others strive for name and fame. Both mistakenly believe that once they attain their ends, they will have peace and happiness. But happiness is not something one gains from objects.

In fact, desires stand in the way of true happiness. This happiness will reveal itself only when the mind stops hankering after one thing or the other. This understanding must become clear in our hearts. This is the first step to peace and happiness.

The Self is the source of eternal bliss and peace. Not realising this, some seek comfort in drink and drugs. By so doing, they not only ruin their own lives, they also hurt their families and society. Spirituality gives us an understanding of who and what we really are. This understanding makes us aware of our responsibilities, and we will then live in such a way as to benefit both ourselves and the world.

Happiness is not something one gains from objects. In fact, desires stand in the way of true happiness. This happiness will reveal itself only when the mind stops hankering after one thing or the other. This understanding must become clear in our hearts. This is the first step to peace and happiness.

(The writer is a world-renowned spiritual leader and humanitarian)

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Finding the road to peace - The New Indian Express

Cardinal Parolin to visit Ars and Lourdes in August – Vatican News

The Vatican Secretary of State will pay a visit to Ars on the Feast of St John Vianney, and will celebrate Mass on the Solemnity of the Assumption in Lourdes.

By Sr Bernadette Mary Reis and Adelaide Patrignani

In early July, Father Patrice Chocholski, the Rector of the St John Vianney Shrine in Ars, confirmed the August 4th visit of the Cardinal Secretary of State Pietro Parolin.

Cardinal Parolin accepted the invitation extended to him to celebrate Mass at 10:00 am and speak at a conference at 3:00 pm. The theme chosen for the conference is Pope Francis and the priest: walking with the People of God.

This is the Cardinals first trip outside Italy since the coronavirus lockdown began in early March.

In an interview with Vatican News, Fr Chocholski explains that Cardinal Parolins presence for this occasion comes just one year after Pope Francis wrote a letter to priests on the 160th anniversary of St John Vianneys death. In that letter, Fr Chocholski says Pope Francis encouraged us to be priests today through a different style. He continued saying that priests need to look to St John Vianney as an example of how to be configured with Christ. This, he said, is a source of inspiration.

Fr Chocholski looks forward to Cardinal Parolins visit and expect him to be a source of encouragement as well.

I am sure that the Secretary of State will encourage us once again, in the spirit of Pope Francis, to live the beauty of our mission today. The Holy Father, Pope Francis, wants us to live this beautiful mission we have received through the call of the Lord and the Church.

Cardinal Parolins conference will be live-streamed on the Shrines Facebook page, Fr Chocholski says.

Listen to our interview with Fr Patrice Chocholski

Also on Tuesday, Cardinal Parolin will dedicate a path within the Shrine to Cardinal Emile Biayenda, the late Archbishop of Brazzaville. The Archbishop died in 1977 and his cause for canonization is in progress. His connection with the Ars Shrine began when he was a student at the Catholic University of Lyon. He would often go to the Shrine to immerse himself in St John Vianneys spirituality. After returning to Congo, he would pay a visit to the Shrine each time his travels took him to France.

The inauguration of the path dedicated to this Christian, Bishop and Cardinal who was deeply inspired by the spirituality of St John Vianney demonstrates how the saints spirituality can still inspire today says Fr Chocholski.

Even in our century with our different cultures in the world, there is a way to live the deep spirituality of St John Vianney as a parish priest.

For the third time since his appointment as Secretary of State, Cardinal Parolin will visit the Shrine in Lourdes. His first visit in February 2017 was in an official capacity representing Pope Francis on the World Day of the Sick. Almost a year later, he returned to Lourdes to speak at the International St Francis de Sales day, dedicated to Catholic media professionals.

His third visit will consist in the celebration of Holy Mass on the Solemnity of the Assumption, 15 August, which also takes place during the 147th National Pilgrimage organized by the Assumptionist Fathers.

Due to Covid-19 restrictions in place, the celebration will take place without the presence of the sick. However, the Mass those who are not able to be present can unite themselves spiritually and participate in the Mass via the internet.

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Cardinal Parolin to visit Ars and Lourdes in August - Vatican News

Lexington gym owner promotes mind, body and spiritual wellness – ABC 36 News – WTVQ

LEXINGTON, Ky. (WTVQ) An expo Saturday morning focused on wellness of the mind, body and spirit for frontline workers and the Black community in Lexington.

The event was hosted by Ebony Cooper, owner of Fit & Fierce Studio, and the Kentucky Nurses Association.

Cooper says opening her gym was the start of her personal health journey, which she says she began after her dad died of brain cancer. Now, she says she wants to encourage everyone to start their own path to wellness.

Im just really big on community, says Cooper. I didnt have the support that I needed.

So she says events like the one Saturday are important to her. She says she wanted to show appreciation for frontline workers who often put others ahead of themselves.

We just wanted the opportunity just to give back and let them know that we see them, says Cooper. We appreciate the work that theyre doing and it doesnt go unnoticed.

In addition, the event also tackled the health disparities seen in the black community, which is something she says she struggled with.

Nutrition is very, very important, says Cooper. When i was growing up, everything was fried. We ate the same foods. Even as an adult, I made the same meals over and over again.

Arica Brandford has been a nurse for more than twenty years. She says a few factors that play into the disparities are lack of resources, such as education, transportation and healthy food in Black neighborhoods.

She says thats why its important to go to the source.

You have to have the initiative and the drive to want better and want more, says Brandford. The other thing thats really important is that you have individuals that come to you and provide mentorship, resources, so its a two-way street.

Brandford is a member of Fit & Fierce, where she says her wellness journey started four years ago. The two share a close bond, having both loss their fathers.

As a nurse, and as a person who is used to putting others first, she had to teach me to put myself first, says Brandford about Cooper.

Cooper says Fit & Fierce provides more than just exercise, but a place to start fresh.

It doesnt matter what your age is, says Cooper. It doesnt matter what your health situation is. Today is always a good day to start.

Brandford says the Kentucky Nurses Association hopes to partner with Fit & Fierce again in the near future.

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Lexington gym owner promotes mind, body and spiritual wellness - ABC 36 News - WTVQ

Indian players are rising to the occasion offering users familiarity of homegrown social networks – The Financial Express

By Shriya Roy

The issue of data privacy has come to the fore again in recent times as social media giant Twitter saw a massive breach in which many accounts, including those of celebrities, got hacked. Closer home, privacy concerns led to the banning of Chinese social media apps like TikTok, adding to fears of user data being vulnerable.

This growing threat is now leading many to homegrown social media apps. As a result of which theres been a boom in their user base. GolBol, Indias leading homegrown social media network, has gained over one million users. Launched in December 2019, the aim of the platform was to help people make relevant and meaningful connections in the virtual world based on similar interests, ranging from faith and kinship to occupation. GolBol, which allows usersto share their experiences and thoughts, is available in Hindithe platform aims to encourage the active participation of Indian users. It sees over three million likes being generated each month and contains more than two million images, all of which are user-generated. We noted that despite cutting-edge technology, social media networks were not fulfilling their purpose of being inclusive and bringing people together. We were motivated by this to create a platform that allows meaningful engagement and connections between people, says Shanu Vivek, CEO, GolBol.

Another homegrown social media platform that focuses on privacy and aims to rival top players like Facebook is Elyments. Vice President M Venkaiah Naidu, in fact, unveiled the Elyments app in a virtual launch on July 5, urging Indians to adopt the Atmanirbhar Bharat campaign. It is available in 10 languages, including Tamil, Telugu, Kannada and English and helps users connect and converse with friends, share updates, network with like-minded people and make voice and video calls as well. User data security has been an issue with many social media applications, but Elyments creator, Sumeru Software Solutions, claims that data will not be shared without users consent. Plus, all its servers are hosted within the country. The app has also taken the cue from social networking giant Facebook and included features such as Feeds, Discover option, as well as alerts on its interface.

Another such player is Flik. The social networking app, however, offers a separate feature for dating unlike other traditional social media platforms. Much like Instagram and Facebook, users can also add live stories to share with friends. They can send instant chat requests and send unlimited images, videos, photos, documents, etc. Many users call it a hybrid version of social networking apps WhatsApp, Twitter, Facebook and Instagram.

Then there is Rgyan, a socio-spiritual networking platform, built specifically for Indians. Users often call it a spiritual Instagram with a touch of Quora. At a time when social media sites hardly have any bar over the kind of content published on them, Rgyan stands out as a platform where only meaningful content is shared.

The app, which is available in both English and Hindi, allows users to share their thoughts through pictures, videos, text and GIFs. Content shared on Rgyan is centred around spirituality, health and wellness, motivational quotes and other topics. It also offers curated content on divinity, horoscope, spiritual and social matters, among others. There was a need for such a meaningful social platform where people could get knowledge, as well as share thoughts on various meaningful matters, says Debjit Patra, founder and chairman, Rgyan.

Apart from these, home-grown social media apps like Chingari, ShareChat and Roposo have also taken over the market after the ban on Chinese apps in India. With more and more Indian apps joining the bandwagon, its clear that the issue of data privacy is gaining more focus.

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Indian players are rising to the occasion offering users familiarity of homegrown social networks - The Financial Express

Rural Development Minister: Eid-Ul-Adha brings spiritual renewal – Loop News Trinidad and Tobago

Rural Development and Local Government Minister Kazim Hosein, a devout member of the Muslim community, has extended Eid Mubarak greetings to his brothers and sisters ofthe faith.

Hosein said having completed fasting on the day of Arafah, Muslims are reminded that the most significant prayer is that performed on this day where Prophet Mohammed recited: There is nothing that deserves to be worshipped in truth except Allah, He is Alone and has no partner, to Him belongs the dominion and to Him belongs all praise, and He is All-Powerful over all things.

He said for Muslims who are not performing Hajj, fasting on the day of Arafah rewards forgiveness for two years.

The Minister further explained that Eid-Ul-Adha is the greater of both Eids with the 10-day fast being more significant than that which occurs during the month of Ramadan.

One of the primary reasons for this is because Eid Ul-Adha commemorates Prophet Abrahams unyielding commitment to his faith, through his willingness to sacrifice his son Ismail. Before he could carry out the sacrifice, Allah recognized his act of devotion and intervened, providing a lamb as an offering to take Ismails place.

It also marks the end of the holy pilgrimage where billions of Muslims across the world would come together to give honour to the spirit of sacrifice.

Health precautions implemented to stem the spread of COVID-19 have unfortunately preventedthe annual pilgrimage making the Hajj impossible for many.

Notwithstanding this obstacle, my fellow brothers and sisters in Islam remain grateful for the opportunity to worship at our mosques in the company of our friends and families. Similar to last months Eid-ul-Fitr celebration, this sacred occasion teaches us that our sacrifices are always rewarded by Almighty Allah (swt).

Despite practitioners of Islam being unable to complete Hajj, Eid-Ul-Adha brought us both a physical and spiritual lesson in sacrifice. I truly believe that because of our discipline, sacrifice and faith in the Almighty, we were able to celebrate this observance in a more profound manner. COVID-19 has taught us that we as Muslims must continue to seek redemption, to forgive and be forgiven. It has also reminded us that every sacrifice that we make in our lives often leads to a greater reward.

Hosein said he has drawn closer to Allahover the past few months, with his appreaciation for his loved ones increasing exponentially. He said he also has a greater desire to continue helping those less fortunate in his community and his country by extension.

This experience has showed us the value of simple devotion, reminding us that sacrifice is a key aspect of not only spiritual development but also spiritual renewal.

On behalf of the Ministry of Rural Development and Local Government, I extend Eid-Ul-Adha greetings to ournational Muslim community at home and abroad, and wish for all citizens of our beloved nation peace, good health and prosperity for every day of your journey through life.

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Rural Development Minister: Eid-Ul-Adha brings spiritual renewal - Loop News Trinidad and Tobago

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

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.


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

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…

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

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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

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

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

miRagen, Investigators from Goethe University and University Hospital Frankfurt and Servier Publish MRG-110 Phase 1 Pharmacodynamic Biomarker Data in…

FRANKFURT, Germany and BOULDER, Colo., July 28, 2020 (GLOBE NEWSWIRE) -- Goethe University, University Hospital Frankfurt and miRagen Therapeutics, Inc. (NASDAQ: MGEN), a clinical-stage biopharmaceutical company focused on the discovery and development of RNA-targeted therapies, today announcedthat preliminary results from a Phase 1 trial detailing the pharmacodynamic activity of MRG-110 has been published in the peer-reviewed journal Nucleic Acid Therapeutics.

We are pleased to have these Phase 1 mechanism of action results for MRG-110 published in Nucleic Acid Therapeutics, said William S. Marshall, Ph.D., President and CEO of miRagen Therapeutics, Inc. These data show that a single systemic dose of MRG-110 reduced detectable miR-92a levels in the peripheral blood of humans and led to the regulation of several well established miR-92a target genes.

The preliminary characterization of MRG-110 pharmacodynamic activity in the peripheral blood of humans provides important insight into the development of potential blood borne mechanistic biomarkers for miR-92a inhibition, added Prof. Dr. Stefanie Dimmeler, Director of the Institute for Cardiovascular Regeneration at the Center for Molecular Medicine, Goethe University Frankfurt. We believe these data provide the basis for further development of readily monitorable biomarkers that can be employed in future clinical trials.

The article, titled Efficiency and Target Derepression of Anti-miR-92a: Results of a First in Human Study, reports mechanistic results from a single ascending dose, double-blind, placebo-controlled, randomized Phase 1 clinical trial. The trial was a study where MRG-110 was administered systemically by intravenous dosing. miR-92a levels were measured in whole blood, circulating endothelial cells, and circulating extracellular vesicles before and after MRG-110 administration. miR-92a levels were found to be significantly reduced in all three of the sample types tested. Importantly, two miR-92a target genes were derepressed after treatment, indicating the intended mechanism of action of MRG-110 in normal healthy volunteers. These data may identify a strategy for measuring pharmacodynamic activity of MRG-110 in peripheral blood in future clinical trials. This would allow for monitoring the intended mechanism of action in blood samples during the conduct of clinical trials in patients, thereby providing an enhanced degree of confidence that the product candidate is affecting the biological pathway that is intended.

Work reported in the article was the result of a collaboration between Goethe University, University Hospital Frankfurt, miRagen Therapeutics and Les Laboratories Servier. Financial support for the studies was also provided by the German Centre for Cardiovascular Research (DZHK).

About miRagen Therapeutics, Inc.miRagen Therapeutics, Inc. is a clinical-stage biopharmaceutical company discovering and developing proprietary RNA-targeted therapies with a specific focus on microRNAs and their role in diseases where there is a high unmet medical need. miRagen has three clinical stage product candidates, cobomarsen, remlarsen, and MRG-110. miRagens clinical product candidate for the treatment of certain cancers, cobomarsen, is an inhibitor of miR-155, which is found at abnormally high levels in malignant cells of several blood cancers. miRagens clinical product candidate for the treatment of pathological fibrosis, remlarsen, is a replacement for miR-29, which is found at abnormally low levels in a number of pathological fibrotic conditions, including cutaneous, cardiac, renal, hepatic, pulmonary and ocular fibrosis, as well as in systemic sclerosis. MRG-110, an inhibitor of miR-92, is miRagens product candidate for the treatment of heart failure and other ischemic disease. In addition to these programs, miRagen is developing a pipeline of preclinical product candidates. The goal of miRagens translational medicine strategy is to progress rapidly to first-in-human studies once it has established the pharmacokinetics, pharmacodynamic, safety, and manufacturability of the product candidate in preclinical studies. For more information, please visitwww.miragen.com. For information on clinical trials please visitwww.clinicaltrials.gov.

About the University Hospital FrankfurtThe University Hospital Frankfurt, founded in 1914, is one of the leading academic hospitals in Germany. It offers its patients optimal medical care in 32 medical clinics / institutes. University hospital and faculty of Medicine together operate a total of 20 research institutes. The close connection to research ensures patients the prompt implementation of new knowledge in therapeutic practice. Around 1,500 inpatient as well as day clinic beds are available. Numerous institutes are dedicated to medical-scientific specialized services. Annually we take care of 51,000 inpatients and 227,000 outpatients. The University Hospital Frankfurt has special interdisciplinary competence amongst others in the fields of neuroscience, oncology and cardiovascular medicine. As a specialist for organ and bone marrow transplantation, dialysis and cardiac surgery, the clinic takes a special task of supra-regional medical care. Over 4,500 employees (full-time positions) take care of the patients around the clock.

About the German Centre for Cardiovascular Research (DZHK)The German Centre for Cardiovascular Research unites high-ranking scientists from all over Germany. It was founded in 2011 with the aim of bundling expertise in cardiovascular research and making it more effective so that research results can be transferred more quickly into clinical application. 1800 researchers from seven partner sites and 30 partner institutions, including university hospitals and non-university research institutions, are involved in the DZHK.

Note Regarding Forward-Looking Statements

This press release may contain forward-looking statements that involve substantial risks and uncertainties for purposes of the safe harbor provided by the Private Securities Litigation Reform Act of 1995. All statements contained in this press release other than statements of historical fact, including statements regarding miRagens strategy, anticipated clinical development milestones, prospects, plans and objectives of management are forward-looking statements. The words believe, may, will, estimate, continue, anticipate, intend, plan, expect, predict, potential, opportunity, goals, or should, and similar expressions are intended to identify forward-looking statements. Such statements are based on managements current expectations and involve risks and uncertainties. Actual results and performance could differ materially from those projected in the forward-looking statements as a result of many factors, including, without limitation: that miRagen has incurred losses since its inception, and anticipates that it will continue to incur significant losses for the foreseeable future; future financing activities may cause miRagen to restrict its operations or require it to relinquish rights; miRagen may fail to demonstrate safety and efficacy of its product candidates; miRagens product candidates are unproven and may never lead to marketable products; miRagens product candidates are based on a relatively novel technology, which makes it difficult to predict the time and cost of development and of subsequently obtaining regulatory approval, if at all; miRagens product candidates may cause undesirable side effects or have other properties that could delay or prevent the regulatory approval; and the results of miRagens clinical trials to date are not sufficient to show safety and efficacy of miRagens product candidates and may not be indicative of future clinical trial results.

miRagen has based these forward-looking statements largely on its current expectations and projections about future events and trends. These forward-looking statements are subject to a number of risks, uncertainties and assumptions, including those described under the heading Risk Factors in miRagens Annual Report on Form 10-K and subsequent periodic and current reports filed with the Securities and Exchange Commission. Moreover, miRagen operates in a very competitive and rapidly changing environment. New risks emerge from time to time.

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Investor Relations Contact:Dan FerryManaging DirectorLifeSci Advisors617-430-7576daniel@lifesciadvisors.com

Corresponding Author: Prof. Dr. Stefanie DimmelerInstitute for Cardiovascular RegenerationCentre of Molecular MedicineGoethe University FrankfurtTheodor Stern Kai 7 60590 Frankfurt; GermanyPhone: +49-69-6301-5158 Fax: +49-69-6301-83462dimmeler@em.uni-frankfurt.de

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