Tag Archive: NBA

  1. Automation, pooling could come next for SalivaDirect as research team juggles authorization requests, media attention

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    Chantal Vogels was not expecting the news on a Saturday morning.

    A postdoctoral fellow in the Grubaugh Lab at the Yale School of Public Health, Vogels helped lead the Emergency Use Authorization submission process for SalivaDirect — a new saliva-based testing protocol for COVID-19 — detailing validation data in the application and collaborating with the U.S. Food and Drug Administration as the process moved along.

    By last week, she could sense the EUA was nearing. She was trading daily emails with the FDA, while Nathan Grubaugh — assistant professor of epidemiology, principal investigator in the Grubaugh Lab and the lead researcher behind SalivaDirect, alongside associate research scientist in epidemiology Anne Wyllie — was spending lots of time on the phone with the regulatory agency.

    On Saturday morning, word suddenly came through: the FDA had issued an EUA for SalivaDirect, permitting other high-complexity laboratories to acquire the testing protocol for use and igniting a flood of popular attention.

    “I think none of us would have expected it to be this big,” Vogels said. “We knew that we were getting to like the final stages … I was expecting it to be Friday or Monday. And then when it came, the media attention has just been crazy. We’ve been so overwhelmed. It’s really amazing to see how well it’s [being] received.”

    Since the EUA has been issued, the team of scientists, accustomed to spending hours inside the lab and out of the limelight, has been ushered onto live news segments and quoted across the internet. Vogels, who is from the Netherlands and completed her bachelors, masters and PhD there, said family and friends in Europe were excited to see her appear live on CNN Monday. Grubaugh spoke with CBS This Morning and ESPN, while Wyllie did interviews with ABC News, MSNBC and more. A Twitter thread describing the test and its benefits from former Obama health care aide Andy Slavitt had garnered more than 22,000 retweets by Tuesday evening.

    Yet as the media attention from Saturday’s EUA has continued into this week, researchers have been even more focused on what might come next, continuing explorations into improvements for the test and outlining a process for disseminating their open-source protocol to interested labs. Researchers are exploring the automation of sample processing, pooling of saliva samples for improved efficiency and modifications to SalivaDirect that would speed up processing by replacing the polymerase chain reaction step.

    “Although SalivaDirect is a big step forward, it’s definitely not the end of it,” Vogels said. “It’s not the solution to everything … It’s a huge step forward, but it’s just one step of the many steps that are still ahead of us.”

    Aside from improvements to the test, one of the most pressing steps for the researchers is distributing authorizations to labs and other groups interested in using SalivaDirect. Annie Watkins MPH ’21, who is helping to process correspondence from interested parties, told the News that the Grubaugh Lab had already received “hundreds of” emails inquiring about authorization by Tuesday morning.

    As part of the terms of the FDA EUA, Yale’s Pathology Clinical Molecular Diagnostic Lab, led by Pei Hui, became the first laboratory authorized to administer and process SalivaDirect. All laboratories that subsequently receive authorization must be certified under the Clinical Laboratory Improvement Amendments of 1988 (CLIA).

    Vogels and Watkins were not able to provide the names of any specific institutions or laboratories reaching out seeking authorization — and could not comment on whether Yale has inquired about using the test for its regular testing of students returning to New Haven this fall — but said the interest originated from a wide spectrum.

    “It’s pretty broad [in terms of] who’s interested in things,” Watkins said. “There’s definitely some universities, university health systems that are interested in return to campus, potentially athletics. And there are one-off labs, there’s a few private practice type things [and some] international labs.”

    The rollout has been complicated by the unique nature of SalivaDirect’s EUA. According to the Grubaugh Lab’s CovidTrackerCT website, SalivaDirect — which is not a testing kit for sale — is the first protocol to receive an EUA from the FDA. The protocol is currently posted as an open source, but “testing is limited to laboratories designated” by the Yale School of Public Health, per the terms of the FDA EUA.

    SalivaDirect is the first protocol to receive an EUA from the FDA. (Photo: Sonia Ruiz)

    Grubaugh wrote in a Twitter thread on Tuesday evening that due to the novel nature of the EUA, his team has to work with Yale and the FDA to come up with the legal conditions surrounding authorization as well as formalizing the regulation of the whole process. Once these regulations are in place, they will start by authorizing labs that will test schools, Grubaugh wrote.

    The lead researcher, whose lab previously studied mosquito-borne viruses before the emergence of COVID-19, also addressed some misconceptions surrounding the testing protocols. 

    “What isn’t SalivaDirect?” Grubaugh wrote. “It isn’t a point-of-care or an at-home rapid test. It uses PCR, and thus requires a high-complexity lab … We don’t have products to distribute. Rather, for authorized labs, we can provide a protocol for doing inexpensive saliva-based RT-qPCR testing.”

    He also noted that while SalivaDirect testing is not yet available to the public, the lab is working to create partnerships to allow for this in the future.

    According to researchers, the next innovations for SalivaDirect include automation, rapid detection and pooling.

    Automation will require the validation of robotic systems and will hopefully be applied to the sample processing and/or PCR steps. With regards to the second goal, Grubaugh wrote that they are also working on replacing the PCR step altogether, with either loop-mediated isothermal amplification or recombinase polymerase amplification. Pooling would allow researchers to combine saliva from many people and test it simultaneously, which could increase testing capacity and utilize reagent resources more efficiently. 

    Watkins said that running one plate with PCR ideally only takes three hours. But other variables, including transport time and high volume, can lengthen the process.

    “It really depends on the lab,” Vogels added. “There’s a step between collecting the sample, getting it in the lab, doing the test, sending out a result, so in an ideal world the protocol itself might be a couple hours, but it’s not a rapid test.”

    All laboratories that receive authorization must be certified under the Clinical Laboratory Improvement Amendments of 1988. (Photo: Lukas Flippo)

    The lab’s study with the NBA — which offered funding for the validation process — is ongoing as researchers continue to explore how SalivaDirect works for asymptomatic detection. They are monitoring samples from one team outside of the bubble, according to Watkins, after players have stopped testing positive in the Orlando bubble. Vogels said the NBA study is also being used to study pooling. 

    SalivaDirect’s current EUA permits the test for “individuals suspected of COVID-19 by their healthcare provider.” The team could submit another EUA for asymptomatic screening with data from the NBA study, Watkins said, but FDA rules around tests for asymptomatic surveillance continue to evolve.

    “As far as I know, I think there’s only one test or a few tests that have been authorized for testing asymptomatics,” Vogels said. “So I think this is really a dynamic process of figuring out what does it really mean, where can we apply this, and how does that really work, so we’re still working closely with the FDA to figure that out.”

    Finally, performing bridging studies could also allow researchers to show the FDA that using different reagents or instruments down the road might work just as well, helping make the testing protocol more flexible for a wider range of labs. 

    But first come the emails that continue to pour in. For the researchers, this journey has been all-consuming but rewarding nonetheless.

    “I’ve kind of forgotten that I’m a student,” Watkins said. “I’m supposed to be registering for classes this week, and I forgot the classes were a thing to be completely honest. This has become my life, and the student aspect seems like a previous life.”

    William McCormack | william.mccormack@yale.edu  

    Charlotte Zimmer | charlotte.zimmer@yale.edu

  2. With data from NBA study, FDA extends Emergency Use Authorization to Yale’s SalivaDirect COVID-19 test

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    On Saturday morning, the U.S. Food and Drug Administration (FDA) granted an Emergency Use Authorization for SalivaDirect, a saliva-based test for COVID-19 developed by researchers at the Yale School of Public Health.

    The EUA paves the way for other labs that hope to begin use of the test, noted for being inexpensive to produce and implement, with the general public. 

    In mid-May, the NBA approached the Yale team behind SalivaDirect, curious about a potential partnership that could help validate their new saliva-based assay. The collaboration generated a plan to verify the test, as players from 22 of the NBA’s 30 teams embarked on their own experiment to recreate the season in a bubble.

    Now, with the NBA-Yale study ongoing and basketball back in action, both experiments are proving successful. The test will now be rolled out this week, according to Anne Wyllie, the associate research scientist in epidemiology who helped spearhead this research at Yale.

    A non-peer-reviewed preprint published earlier this month by lead researchers Wyllie and Nathan Grubaugh, an assistant professor of epidemiology, found the test to be “highly sensitive” with “high agreement” in testing outcomes when compared to widely used ThermoFisher Scientific nasopharyngeal (NP) swabs. The test is validated for use with reagents and instruments from multiple vendors, which researchers hope will minimize supply chain bottlenecks.

    “Providing this type of flexibility for processing saliva samples to test for COVID-19 infection is groundbreaking in terms of efficiency and avoiding shortages of crucial test components like reagents,” FDA Commissioner Stephen Hahn said in an official release.

    Other saliva tests approved by the FDA, like one developed by Rutgers, are far more expensive than SalivaDirect. In May, Vault Health was offering the test, conducted in a patient’s home with telehealth video supervision, for $150. According to the August SalivaDirect preprint, reagents for the test could cost as little as $1.29 to $4.37 per sample. Researchers estimate that Proteinase K, used for sample processing, would cost somewhere between 13 and 26 cents a sample. Primers and probes would cost a few cents. And a RT-qPCR kit would require between 75 cents and $2.11 per sample.

    When labs offer tests to the public, each test should only cost $10 or less, Wyllie wrote in an email to the News. From the beginning, researchers have sought an inexpensive, flexible test that could be scaled and immune to bottlenecks.

    “We’ve called it SalivaDirect because of the idea that we’re almost testing saliva directly. We’re doing a very simple intermediate treatment,” Wyllie told the News in June. “That makes it a lot cheaper and makes it a lot more high throughput and faster turnaround.”

    The SalivaDirect sampling process, as shown on the team’s website (Graphic: Courtesy of Anne Wyllie, diagram made using BioRender)

    The NBA study allows researchers to validate the test in an asymptomatic cohort, Wyllie said. In addition to receiving daily testing to ensure that they have not contracted the virus, a group of players, coaches and staff heading for the NBA’s Florida bubble volunteered to offer a saliva test sample that researchers could use to verify the efficacy of SalivaDirect.

    Although she could not yet report on the study itself, Wyllie pointed out that the very success of the NBA bubble in Florida has created a unique challenge for researchers studying a new coronavirus test: there are no positive cases. Before teams entered the bubble at Disney World, 25 of 351 players tested positive for the virus between June 23 and July 2. But of the more than 340 players still receiving constant tests within the bubble, zero positive tests have been recorded over the past month, according to official NBA releases.

    An NBA spokesperson did not respond to an immediate request for comment Saturday on whether the league now plans to begin using SalivaDirect in its normal testing regimen. The NBA and National Basketball Players Association contributed more than $500,000 to fund the validation study for SalivaDirect, ESPN reported Saturday. The researchers’ preprint also lists the Huffman Family Donor Advised Fund, George Mason’s Mercatus Center, the Yale Institute for Global Health and the Beatrice Kleinberg Neuwirth Fund as funders.

    Grubaugh and Wyllie have both emphasized how saliva testing could change the game for detecting COVID-19. Not only has it been proven in their studies to be equally — if not more — effective as nasopharyngeal swab testing, but it is more comfortable for patients and significantly lowers the risk of infection for healthcare workers administering the tests.

    The FDA also explained in its announcement that SalivaDirect is incredibly versatile, as it does not require a particular collection device. Any sterile container will work. 

    “This test is also unique because it does not require a separate nucleic acid extraction step,” the FDA wrote. “This is significant because the extraction kits used for this step in other tests have been prone to shortages in the past. Being able to perform a test without these kits enhances the capacity for increased testing, while reducing the strain on available resources.”

    While the saliva testing method is generally more straightforward than NP swab testing, one of the potential barriers to widespread use of SalivaDirect will be getting adequate saliva samples, according to Wyllie. She said that the sample is supposed to just be “the normal saliva that naturally pools in your mouth.” Often people think it is more complicated than that, and they sniff or cough to produce saliva, which can sometimes reduce the test’s accuracy.

    Lead researchers Nathan Grubaugh, left, and Anne Wyllie (Photos: Yale School of Public Health)

    Wyllie told the News when the NBA study started that the ultimate goal was not to commercialize SalivaDirect, and that the protocols were already available online to the public. The FDA’s statement explains that Yale will now provide these testing protocols to other labs on an “open source” basis.

    “Our goals and values hold true. There is still no kit and no commercialization,” Wyllie told the News in an email. “The method is available but we have to designate labs who can use it to make sure they follow the requirements exactly — just some oversight. However, it also means that we have a free license for commercial labs — we want to have conversations about them for testing.”

    By following the instructions put out by Wyllie and Grubaugh’s team, these labs will be able to get the necessary materials and easily do the test themselves, according to the FDA. This is made possible by the fact that SalivaDirect does not depend on specific equipment from Yale and can be scaled up at other laboratories.

    Instructions on the Grubaugh Lab’s coronavirus-centric website, CovidTrackerCT.com, simply invite labs to email salivadirect@gmail.com to begin the process alongside a link to a detailed protocol that covers collecting spit — thinking about “favorite foods” or an “upcoming meal” can stimulate saliva production — processing the sample and reporting a result.

    “I think people will move to this quite quickly — we need more tests as screening measures as we continue to reopen,” Wyllie wrote in an email to the News. “With more frequent testing we can get this virus under control. I think people are much more open to saliva than swabs!”

    The Yale team submitted SalivaDirect as a laboratory developed test for FDA EUA on July 14, 2020, making SalivaDirect the fifth saliva sample test that the FDA has authorized.

    William McCormack | william.mccormack@yale.edu  

    Charlotte Zimmer | charlotte.zimmer@yale.edu

  3. CUGNON: Break up the band

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    Professional sports are wholly reliant on the presence of competitive drama. Last-second buzzer-beaters, tight overtime contests and high-octane quarterback battles have offered us some of our most cherished and intoxicating sports memories.

    What makes these moments so exciting is the uncertainty of their outcomes. While it sounds a bit obvious to say, close games are simply more enjoyable. Bearing all of this in mind, you’ll not be surprised that I find the modern athletic trend of building “super teams” utterly detestable.

    Outfits like the 2016 Golden State Warriors, the 2015 F.C. Barcelona squad and the 1993 Dallas Cowboys don’t make sports more fun by concentrating some of the biggest stars onto super-charged rosters; they remove the very uncertainty on which spectator sports rely.

    There’s nothing inspiring about the fact that the Golden State Warriors are going to charge out onto the court this season with four of the best 15 players in the National Basketball Association. Sure, you might tune in come the finals to see if LeBron James or some other star might be able to knock them off their perch, but odds are that you’ll probably just switch on the news when the Warriors are tearing your team apart by 45 points in the third quarter.

    Sports rely on competitive balance to keep things fun. The fact that only a handful of NBA teams realistically have any shot at winning a championship in any given season is already a bit boring, but it’s just depressing when one team’s triumph is essentially a foregone conclusion.

    Like it or not, competition drives ratings, and there’s little point in watching if games or series aren’t competitive.

    Frankly, super teams are only exciting to watch when they fail. Take Leicester City’s unexpected run to last season’s English Premier League title as an example. That championship charge was must-see television exclusively because the EPL’s usual championship suspects — Chelsea, Manchester City, Arsenal and the like — seemed to be more interested in enjoying a season-long holiday than in actually winning a title.

    It might sound a bit callous, but I care less about Leicester City than I care about watching big clubs fail. I care more about having the opportunity to watch a title race that is actually suspenseful and exciting. I’m a Chelsea fan, and even I don’t have fun watching them wrap the league up by December.

    When teams like the Warriors win titles, it’s the sporting equivalent of the rich getting richer. It’s about as inspiring as Donald Trump turning a seven-figure loan from his father into an ego-fueled real estate empire. Nobody cares if you win when everything is already stacked in your favor.

    Sure, super teams give us the opportunity for David-and-Goliath clashes where sometimes, every so often, the plucky little guy comes out on top. But those moments are, understandably, few and far between. So please enjoy Leicester City’s championship, everybody, because you may never see anything like it again.

    I know this column is making me sound like a bit of a sports communist, but wouldn’t you prefer to watch a league where there’s a bit of parity or drama? I’m not advocating a redistribution of athletic wealth; I’d just rather not see teams like the 73–9 Warriors sign guys like former Most Valuable Player Kevin Durant, and I would really enjoy not having to watch dumpster fire clubs like the Philadelphia 76ers spend three seasons tanking in an effort to land the necessary assets to build a super team of their own.

    Ultimately, super teams make regular-season games even less interesting and encourage organizations to give up on trying to win. After all, what’s the point of making a playoff push only to enjoy a first-round thrashing at the hands of some league juggernaut? Talent disparity in a sports league is fine, but top-heavy associations with one or two stacked rosters are simply a bore.

    I might ruffle a few Bostonian feathers by saying this, but I don’t care about the fact that Bill Russell won 11 championships with the Celtics in an era where he was essentially competing against one other team, the Lakers. When your team is stacked full of 6-foot-10 athletic freaks and 95 percent of your competition just showed up for the free gym membership, you should be able to win a lot of basketball games. League parity might not help teams tear up record books, but at least it helps keep fans interested.

    Marc Cugnon is a senior in Calhoun College. Contact him at

    marc.cugnon@yale.edu .