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Category Archives: Genetic Medicine

Aleksandar Rajkovic, MD, PhD, FACMG Is Elected to the ACMG Foundation for Genetic and Genomic Medicine Board of Directors – Herald-Mail Media

BETHESDA, Md., April 20, 2020 /PRNewswire/ -- Aleksandar Rajkovic, MD, PhD, FACMG has been elected to the board of directors of the ACMG Foundation for Genetic and Genomic Medicine. The ACMG Foundationis a national nonprofit foundation dedicated to facilitating the integration of genetics and genomics into medical practice. The board members are active participants, serving as advocates for the ACMG Foundation and for advancing its policies and programs. Dr. Rajkovic was elected to a two-year term starting immediately.

ACMG Foundation President Bruce R. Korf, MD, PhD, FACMG said, "We are delighted that Dr. Rajkovic has joined the ACMG Foundation Board of Directors. He brings a wealth of expertise in clinical genetics and genomics, as well as experience in organizing genomic medicine services in a large academic health system."

Dr. Rajkovic is a professor of pathology and obstetrics/gynecology and reproductive sciences at the University of California San Francisco (UCSF). He is the UCSF Chief Genomics Officer and Medical Director and Chief of the Center for Genetic and Genomic Medicine (CGGM) that organizes, coordinates and oversees clinical genetics and genomics services across the entire UCSF Health system. He also serves as the Director of the Genomic Medicine Initiative there. Dr. Rajkovic earned a Bachelor of Science in Chemistry from Johns Hopkins University and his MD/PhD in Medicine and Molecular Biology from Case Western Reserve University. He is board certified in both clinical genetics and genomics and obstetrics and gynecology. Dr. Rajkovic previously acted as medical director for the clinical genomics laboratories at UPMC Magee-Womens Hospital, served as medical director for the genetic counseling and diagnostic services at Magee and as program director of the University of Pittsburgh School of Medicine residency/fellowship in medical genetics. He was co-chair of the NIH Fragile X-Associated Primary Ovarian Insufficiency Meeting and served on the NIH Genetics Health and Disease Panel. He was a founding member of Doctors for Change, Houston, Texas, an organization dedicated to improving access to healthcare for all. He has authored 129 peer-reviewed publications and has been a frequent invited presenter at prominent medical meetings.

Upon being elected to the ACMG Foundation Board of Directors, Dr. Rajkovic said, "I am looking forward to working with other directors in advancing the ACMGF mission."

A complete roster of the ACMG Foundation board can be found at http://www.acmgfoundation.org.

About the ACMG Foundation for Genetic and Genomic Medicine

The ACMG Foundation for Genetic and Genomic Medicine, a 501(c)(3) nonprofit organization, is a community of supporters and contributors who understand the importance of medical genetics and genomics in healthcare. Established in 1992, the ACMG Foundation supports the American College of Medical Genetics and Genomics (ACMG) mission to "translate genes into health." Through its work, the ACMG Foundation fosters charitable giving, promotes training opportunities to attract future medical geneticists and genetic counselors to the field, shares information about medical genetics and genomics, and sponsors important research. To learn more and support the ACMG Foundation mission to create "Better Health through Genetics" visit acmgfoundation.org.

Kathy Moran, MBAkmoran@acmg.net

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Aleksandar Rajkovic, MD, PhD, FACMG Is Elected to the ACMG Foundation for Genetic and Genomic Medicine Board of Directors - Herald-Mail Media

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Genetic predisposition to smoking in relation to 14 cardiovascular diseases. – Physician’s Weekly

The aim of this study was to use Mendelian randomization (MR) to determine the causality of the association between smoking and 14 different cardiovascular diseases (CVDs).Our primary genetic instrument comprised 361 single-nucleotide polymorphisms (SNPs) associated with smoking initiation (ever smoked regularly) at genome-wide significance. Data on the associations between the SNPs and 14 CVDs were obtained from the UK Biobank study (N=367643 individuals), CARDIoGRAMplusC4D consortium (N=184305 individuals), Atrial Fibrillation Consortium (2017 dataset; N=154432 individuals), and Million Veteran Program (MVP; N=190266 individuals). The main analyses were conducted using the random-effects inverse-variance weighted method and complemented with multivariable MR analyses and the weighted median and MR-Egger approaches. Genetic predisposition to smoking initiation was most strongly and consistently associated with higher odds of coronary artery disease, heart failure, abdominal aortic aneurysm, ischaemic stroke, transient ischaemic attack, peripheral arterial disease, and arterial hypertension. Genetic predisposition to smoking initiation was additionally associated with higher odds of deep vein thrombosis and pulmonary embolism in the UK Biobank but not with venous thromboembolism in the MVP. There was limited evidence of causal associations of smoking initiation with atrial fibrillation, aortic valve stenosis, thoracic aortic aneurysm, and intracerebral and subarachnoid haemorrhage.This MR study supports a causal association between smoking and a broad range of CVDs, in particular, coronary artery disease, heart failure, abdominal aortic aneurysm, ischaemic stroke, transient ischaemic attack, peripheral arterial disease, and arterial hypertension. The Author(s) 2020. Published by Oxford University Press on behalf of the European Society of Cardiology.

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Through tech, USC museums and galleries keep people connected to art – USC News

From the assassination of President John F. Kennedy to the 9/11 attacks and civil unrest in Los Angeles, the USC Fisher Museum of Art managed to stay open.

Not this time. In the wake of the COVID-19 pandemic, the museum closed its doors on March 14 for the first time in its more than 80-year history.

This decision was not made lightly, said Selma Holo, executive director of USC Museums and Galleries. This is in step with USCs current COVID-19 response and with the evolving national health guidelines designed to slow potential transmission of the coronavirus.

Once the doors were closed, though, Holo had an idea.

Inspired by the art worlds move to social media to promote digital art content, Holo and her team introduced the hashtag #MyMuseumAtHome to encourage staff to share privately owned art from their homes.

The initial idea was to get a peek into the art that museum professionals choose to surround themselves with at home, Holo said. Then we thought it would be fun not just to see the artwork belonging to museum staff but everyones at-home collections.

In addition, Holo added, posting art online is a tremendous opportunity to call attention to makers and artists who are likely suffering greatly due to the closing of museums and art venues in Los Angeles and around the world.

It is a recognition that we are in a unique moment. Not only in regard to the current crisis, but a moment when technology photography, video, web platforms and social media allows museums to continue to the serve their audiences and extended online audiences exponentially larger than those who might walk in the doors of any single museum, she said.

Just because we cant be standing in front of the art doesnt mean that we cant continue to enjoy it and perhaps even see it in new ways, said Holo, who is also a professor of art history at the USC Dornsife College of Letters, Arts and Sciences, where she teaches museum studies.

When the museums eventually open again, even the savviest Trojan may be surprised to learn that USC is the home of four museums and 11 art galleries. Holo said revealing those hidden treasures to the community is job No. 1.

USC is a polyphonic constellation of museums and galleries that have relevant, dynamic and empowering exhibitions, she said. As executive director of USC Museums and Galleries, it is my goal to explore what each of our museums and galleries is doing and to share that collective knowledge among all of us in an effort to remain a major cultural force not only in Los Angeles but worldwide.

Selma Holo said that one reason to post art online is to call attention to makers and artists who are likely suffering greatly during the closing of art museums and art venues around the world. (Photo/Courtesy of Selma Holo)

Holo added that USC is in a notable position: Two of its museums the USC Fisher Museum of Art and the USC Pacific Asia Museum in Pasadena are accredited by the prestigious American Alliance of Museums. Out of some 55,000 museums worldwide, only 1,080 museums are accredited by the alliance.

There is also the importance of location. USC sits in the heart of L.A.s museum alley in Exposition Park. In fact, the USC Fisher Museum of Art was on museum alley before one even existed. The museum established in 1939 by Elizabeth Homes Fisher as the USC Fisher Gallery was the first local museum dedicated exclusively to art.

The L.A. art world doesnt have anything else like that, Holo said. For 80-plus years, we have been a leading stable and credible artistic presence not only at USC but in the city of Los Angeles.

The USC Pacific Asia Museum also offers its own unique history, with art dating back 4,000 years to Chinas Ming Dynasty. Its director, Bethany Montagano, said visitors can also expect a focus on the future.

Were definitely looking toward contemporary art exhibitions that will resonate with our current social issues, Montagano said. We want to be a place that supports cutting-edge dynamic contemporary art exhibitions that will launch new artists careers.

In addition, Holo believes USCs University Park Campus should be seen as a mecca for art enthusiasts. USC is certainly a destination for art, with a staggering number of art and cultural venues to visit, she said.

While many USC museums and galleries are known to the public, there are a select few that some visitors might not know exist but are worth exploring once the shelter-in-place policy is lifted and the university reopens.

The Sophie Davis Gallery is at the USC Leonard Davis School of Gerontology. (USC Photo/Gus Ruelas)

The Sophie Davis Gallery

The city of Los Angeles has long been labeled a youth-obsessed culture, but thats not the case at the USC Leonard Davis School of Gerontology. In fact, inside the schools Sophie Davis Art Gallery, aging is an art form. The gallery celebrates older artists and explores topics related to aging across the lifespan through the lens of creativity.

This gallery supports the idea of art transcending age, Holo said. In essence, an artist might physically age but his or her vision of art is eternally vital, robust and ageless.

The displays in the Viterbi Museum are not necessarily what one might expect in a museum. (Photo/Chandrea Miller)

The Viterbi Museum

Holo was also quick to point out that USCs museums do not fit a particular mold as seen in the display at the Viterbi Museum, located at the USC Viterbi School of Engineerings Tutor Hall. The gallery displays revolutionary digital and electric devices that the schools namesake, Andrew Viterbi, pioneered equipment that connects cellphone technology to the internet.

At this gallery, expect the unexpected, Holo said.

LOVE by Robert Indiana is displayed at the Lawrence J. Ellison Institute for Transformative Medicine of USC in West L.A. (Photo/Courtesy of the Ellison Institute)

Lawrence J. Ellison Institute for Transformative Medicine of USC

Holo also calls attention to art as creating a positive change in the world, whether it be to inspire, calm, breed creativity or push us to think differently.

Thats a sentiment shared at the gallery space at the Lawrence J. Ellison Institute for Transformative Medicine of USC in West L.A., where the goal is to foster collaborative insights into cancer and health where art plays a pivotal role in the experience that patients and visitors have when they step foot inside.

We believe along with the Ellison Institute that art can be healing and inspiring, Holo said. The LOVE sculpture sits in the heart of the building and is a constant reminder of what drives the researchers, clinicians, patients and staff every day.

The video wall and Annenberg Art Gallery

The photographic journey of Wang Wenlan is on display in the Annenberg Art Gallery. (Photo/Courtesy of Wang Wenlan)

Finally, Holo notes that a museum that doesnt generate new knowledge is a dead museum. She notes the USC Annenberg School for Communication and Journalisms knowledge-driven video wall in the lobby of Wallis Annenberg Hall.

Right when you walk in, there is a three-story floating video screen, Holo said. Its literally a kind of contemporary art in motion, transferring knowledge at lightning speed.

In addition, there is the schools more traditional Annenberg Art Gallery that features a variety of art from paintings and sculptures to famous international photographers.

Together we can have a greater cultural impact than any one of our galleries or museums could do singularly, Holo said. My message is merely to say, Were all here for our USC community and Los Angeles neighbors, and were going to make your lives better through the transformative power of art and the evidence of our exciting material culture located at every corner of our campus.

Holo noted that the closure of USCs museum and galleries is temporary. When the doors reopen, she feels its vital that visitors experience the art in person.

The most enduring thing about museums is that they allow us to experience art in a situation that is essentially social. That communal experience can be exhilarating or consoling, confirming or challenging, she said. Museums provide us with physical, authentic portals into the great creativity of humanity that can only be hinted at online.

More stories about: Art History, COVID-19, Fine Arts, Museums

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The future of medical technology devices in the time of COVID-19 – MobiHealthNews

As COVID-19 sweeps around the world, we are starting to see countries exit from lockdown, others introducing more stringent lockdown and others relying on the resilience of their health and care systems to allow them to make changes which are more discreet and focused on trying to avoid the economic and political effects of more stringent approaches.

Health and care systems are having to adopt to this new world and suddenly, the old ways of working which relied largely on an analogue world and the bricks and mortar of the 'office visit'are starting to look more outdated and out of step with the environment they are working within.

There is an interesting parallel here. Human Coronavirus are a group of viruses that change small parts of their genetic code as part of their life cycle. Thus, they mutate as a matter of course. The challenge is for our health and care systems to also be able to mutate at pace and scale. We have never seen this happening before but happening it is, with digital transformation, the use of medical technological devices, the application of AI in the care of people becoming more commonplace.

This is also being accompanied by other significant changes, particularly around the deployment of a whole gamut of new devices and products including wearables which together with the dissemination of a 5G infrastructure and the very sudden increase in take up, are leading to a veritable explosion in the number of data points which are going to become available to different health and care systems globally.

It is now accepted that these changes are here to stay.Not only is COVID-19 a pandemic which is unlikely to vanish with the summer sun in the northern hemisphere, but there is a real urgency to develop the insights we need to deploy AI and improve and personalise the care of people who will be affected on the second wave of contagion which is likely to creep up on us in the autumn above the equator. This means that the reliance on medical technological solutions will increase and increase at a pace and scale we have not witnessed before.This has many potential entry points in the best management of COVID-19 pandemics.From the monitoring of mild cases at home, to the personalised care of patients post discharge from hospitals, at both ends of the COVID-19 journey. To this can be added the better management of contact tracing, and more systematic and technologically enabled monitoring of workforce which is already a scarce resource.

There is also another and often forgotten, dimension.The monitoring of existing non-communicable diseases, largely displaced as the central activity of health systems who are totally focused on managing the pandemic, will require new solutions and the potential here for technology and digital solutions to enable better self-care is considerable.

It is therefore really unlikely that this is a temporary phase.The post COVID-19 world in the 2020s is going to be very different to what came before it.

So, what are some attributes which will make some devices stand out?

Obviously, they need to fulfil a tangible need and be good enough in terms of accuracy, reliability, safety and reproducibility to be deployed at scale.This is largely self-evident but there are five other aspects of how they are deployed which may appear to be less obvious but in fact are equally important.

Thus, the future for med tech is rosy.First movers and fast followers will reap the benefits of easier adoption and incorporation into the mainstream as long as they are true to these principles.

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Seattle Genetics wins another speedy approval as FDA clears breast cancer drug – BioPharma Dive

Dive Brief:

Nearly 15 years passed from Seattle Genetics' 1997 founding to approval of its first drug, Adcetris. Now, in the span of four months, the biotech's added two more.

First came the bladder cancer drug Padcev, which the FDA approved on an accelerated basis in December and Seattle Genetics co-developed with Japanese drugmaker Astellas.

Like Seattle Genetics' flagship drug Adcetris, Padcev is what's known as an antibody-drug conjugate, or ADC, which combines the targeting power of an antibody with a tumor-killing toxin. The treatment is approved for patients who have failed a few treatments, but Seattle Genetics has a chance to move it into the frontline setting if an ongoing study combining the drug with the Merck immunotherapy Keytruda succeeds.

Approval of Tukysa marks another milestone for Seattle Genetics, which has seen its shares soar to record highs over the past year. Tukysa is an oral kinase inhibitor a common type of cancer drug rather than the ADCs for which the company is known.

Seattle Genetics owns full rights to Tukysa, too, thanks to a $614 million buyout of Cascadian Therapeutics in 2018. Approval expands the company's reach into breast cancer, which affects more women than any other cancer type. The drug costs $18,500 per month at list price, or $111,000 per patient, per year, a company spokesperson confirmed to BioPharma Dive.

As with Padcev, which was approved three months before the FDA's review deadline, Seattle Genetic's Tukysa was cleared well ahead of schedule.

The biotech filed its application in December. The FDA began its review in February, and approved Tukysa two months later. That timeline is in line with some of the fastest drug approvals in recent memory, among them Novartis' breast cancer drug Piqray, the only other new medicine cleared under the FDA's "real-time oncology review" pathway. AstraZeneca and Daiichi Sankyo's breast cancer drug Enhertu also received a fast review.

Tukysa's currently under review in other countries as well under "Project Orbis," a collaborative effort between the FDA and several other international regulators to simultaneously evaluate cancer drugs.

The fast approval came despite the ongoing coronavirus pandemic, which has stretched the healthcare system and drug regulators thin. The agency has hinted drug reviews might slow if other issues, such as maintaining drug supply, become more significant.

But Tukysa's approval shows, at least for now, "how our regular work in reviewing treatments for patients with cancer is moving forward without delay," said Richard Pazdur, the FDA's top cancer drug evaluator, in a statement.

The approval is based on the results from the HER2CLIMB study, in which a regimen of Tukysa, Herceptin and chemotherapy cut the risk of death or disease progression significantly over Herceptin and chemo alone in patients with HER2-positive breast cancer. Those patients had already failed Herceptin and other HER2-targeting drugs, Perjeta and Kadcyla. The most common side effects seen were liver enzyme elevations and diarrhea.

Seattle Genetics also found Tukysa appeared to help patients whose cancers had spread to the brain which occurs in about a quarter of HER2-positive breast cancer patients and that's reflected in the drug's broader-than-anticipated label. The approval "unexpectedly enables" second-line use, whereas patients in the HER2CLIMB study had failed at least two therapies, wrote RBC Capital Markets analyst Kennen MacKay.

Seattle Genetics is testing Tukysa in a Phase 2 study in colorectal cancer that could lead to another fast approval, if successful.

Tukysa was the product of Cascadian, another Seattle-area biotech. Once known as Oncothyreon, Cascadian had a number of clinical setbacks over the years, among them a cancer vaccine known as Stimuvax. But a 2014 licensing deal with Array Biopharma now owned by Pfizer gave it tucatinib, which led Seattle Genetics to buy the company four years later.

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Antibody tests: The promise and pitfalls of using them to reopen the US – PolitiFact

As Americans yearn for a future with work, shopping and outings with friends, one concept may become a crucial prerequisite: the widespread use of antibody tests.

Antibody tests, also known as serology tests, are designed to detect the presence of antibodies proteins that are key elements of the bodys immune response to germs. Antibodies would be present in people who battled the coronavirus and recovered, as well as in people who had been exposed but whose infection was so mild that they didnt notice they were sick.

If someone has antibodies from exposure to the coronavirus, that person should have immunity to the virus, at least for a period of time. (More on that in a bit.) That means they can go out into the wider community without fear of getting sick themselves. Antibody tests could also be helpful for making staffing decisions in medical units treating coronavirus patients.

Anthony Fauci, a top federal official in the fight against the coronavirus, has floated the idea of "immunity certificates" based on antibody testing. "As we get to the point of considering opening the country, it is very important to understand how much that virus has penetrated society," Fauci said on CNN.

Its also a key element of Democratic presidential candidate Joe Bidens plan for reopening the country. And New York Gov. Andrew Cuomo has gone so far as to develop and start implementing an antibody testing system for New York State. "We cannot restart life as we knew it without testing," Cuomo has tweeted.

PolitiFact interviewed several experts about the promise and potential pitfalls of antibody testing.

What has been done so far?

The Food and Drug Administration has already granted an "emergency use authorization" for one particular antibody test manufactured by a company called Cellex. The FDA also green-lighted other tests for the market without the usual review process, as long as they are labeled with disclaimers that the agency has not fully reviewed them.

That enabled more than 90 tests to go to market, some from academic organizations and some from medical companies, according to Politico. The CDC itself is working to produce one. Researchers at Stanford University have produced one test, while Mount Sinais Icahn School of Medicine has produced another.

The key to developing antibody tests is to have an appropriate coronavirus protein, "because thats what antibodies recognize," said Elizabeth McNally, director of the Center for Genetic Medicine at Northwestern Universitys Feinberg School of Medicine.

The tests work by having some viral protein adhered to a surface, McNally said. "A persons blood sample is mixed with a virus protein and is tested for whether there is an interaction between antibodies in the persons blood and the antibody on the surface."

The good news is that many of the tests are not overly complicated, often requiring blood from a self-administered finger prick. Some have a turnaround time as rapid as 10 to 15 minutes.

How accurate are these antibody tests?

Thats the bad news: The tests so far have not been especially accurate.

In mid April, the FDA said the National Cancer Institute would start reviewing tests for accuracy. This move was welcomed by medical experts.

The United Kingdom has already pulled some tests for inaccuracy. Many antibody tests now being rolled out "may not be as accurate as wed like," FDA commissioner Stephen Hahn has acknowledged. Scott Becker, CEO of the Association of Public Health Laboratories, went so far as to label many of the tests "crappy," CNN reported.

"There is very limited data, almost none peer-reviewed, evaluating how well these tests perform," said Elitza S. Theel, director of the infectious diseases serology laboratory at the Mayo Clinic. "So its critical that laboratories carefully perform validation and verification studies to ensure that the test they are offering for clinical testing is accurate."

A key metric will be a tests "sensitivity," which refers to the percentage of positive tests that reflect genuine infections. "Anything less than 99% would mean too many cases in the population are wrongly identified, throwing off population estimates," said Theo Vos, a professor at the University of Washingtons Institute for Health Metrics and Evaluation.

Will antibodies actually confer immunity?

Scientists expect that a past infection will produce some immunity. But they arent entirely certain of it, and it remains unclear how long that immunity could last.

Generally speaking, the degree and duration of immunity from an infection varies depending on the germ in question. Immunity from common cold viruses last a few weeks; immunity from chickenpox can last decades. Many infectious diseases fall somewhere in between.

One hopeful sign is that an infection with the virus that causes SARS, which is similar to COVID-19, produces an antibody response for a year, maybe more. Thats not as long as some diseases, but it could buy time until a successful vaccine is produced, which experts say could happen within 12 to 18 months.

One unknown is whether that immune response from a past coronavirus infection is strong enough to actually preclude a new infection.

COVID-19 probably gives immunity to "most people, but we dont know for sure that is the case in every recovered COVID patient," said Angela Rasmussen, associate research scientist at the Center for Infection and Immunity at the Columbia University Mailman School of Public Health. "We dont know what levels of antibodies confer protection either, so we should not assume that just having antibodies guarantees that you have completely protective immunity. Theres still a lot more to learn."

What are some of the practical challenges of administering tests?

One practical concern is when to collect samples from individuals.

"We know it takes over a week in some cases to mount an immune response to the virus and to develop a detectable level of antibodies," Theel said. "The samples need to be collected at a certain time after symptom onset. Using samples collected too soon would lead to negative results simply because the patient hasnt developed an immune response to the virus yet."

By the same token, additional testing may be necessary to confirm that someone who is antibody-positive is no longer experiencing an active infection that can get others sick.

Another practical issue is where the test should be administered.

"We dont want to have people rushing to a doctors office or a hospital since that could actually worsen the spread of the virus," McNally said. "Some companies are producing small individual test kits which will produce a + or - result. Some of these tests will require a doctors order and some may become commercially available."

For instance, McNallys institution, Northwestern University, is developing a kit that is designed to be sent through the mail. Once returned via mail with a blood drop on specially treated paper, the tested individual can find out their result a few days later through a secure website.

What can antibody testing tell us about society at large, rather than just the individual?

Knowing how many people are immune will be a key element of the decision to reopen the economy. However, undertaking society-wide testing will require coordinated effort.

Already, some studies are under way. The World Health Organization is working on a study of a half-dozen nations, while one effort in the U.S. is already collecting blood samples in such cities as New York, Seattle and Minneapolis. Other studies are occurring in Michigan, Miami and Los Angeles.

One study completed in a hard-hit town in Germany recently found that 14% of those tested had antibodies to coronavirus.

McNally said research studies like these are important because they "allow us to be able to know how the population has developed immunity. We will want to know what percentage of the population has developed antibodies and how this differs across neighborhoods and areas. This is the type of information that will help to guide decisions about bringing people back to work and future safety issues."

What needs to be done to enable large-scale antibody testing?

Vos recommends focusing on a small number of the most promising tests, then scaling up production. The expected high demand for antibody tests should help push companies to do this quickly, he said. In the meantime, he said, poorly performing tests should be restricted and the FDA should accelerate its regulatory process.

"Things are happening quickly, but without strong oversight there will be a flood of undocumented tests in use, muddying the waters for anyone trying to make sense of what is going on in the community," Vos said.

Its also important to note that antibody tests are just one part of whats needed to restart the economy. Experts say it will also require a system of widely available diagnostic tests to determine if someone has an active coronavirus infection, along with "contact tracing," a method of identifying people who were in close proximity to other people who were infected, so that they can be tested and, if necessary, quarantined.

CDC director Robert R. Redfield told NBC News that large-scale antibody testing could fall into place "over the next several months."

McNally told PolitiFact that she expects antibody testing to be ramping up in May.

"We know most people take about four weeks to develop antibodies and immunity, so assuming exposure to the virus occurred in March or April, we really want testing working at scale in May," she said. "I think were on target for that."

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