The U.S. Food and Drug Administration on Saturday issued an emergency permit allowing public use of a saliva-based test for the coronavirus developed at Yale University and funded by the NBA and the National Basketball Players Association.
The test, known as SalivaDirect, is designed for widespread public screening. The cost per sample can be as low as about $ 4, although the cost to consumers is likely to be higher than that – perhaps in some cases around $ 15 or $ 20, according to expert sources.
Yale administered the speech test to a group that included NBA players and staff in the lead after returning from the league to play and compared results with the nasal swab tests that the same group took. The results were almost universally consistent, according to published research that has not yet been peer-reviewed.
The leading coronavirus detection test, developed at a Rutgers University lab and given the same approval by the FDA in mid-April, costs individual consumers up to $ 150 – although in some circumstances this can be reduced to $ 60 or $ 70, said Andrew Brooks, a associate professor at Rutgers and chief operating officer of RUCDR Infinite Biologics, the lab behind the test. The Rutgers test can be taken at home and gives results in 24 to 48 hours.
Several NBA teams used the Rutgers Test in June, and Brooks said several sports teams still use it. Those teams flew saliva samples to one of several labs – including the Rutgers lab in New Jersey – approved for administration of the test, which added time and cost.
The Yale test funded by the league and the players’ union is simple enough to use anywhere through labs, as they go through required accreditation process, said Nathan Grubaugh, an assistant professor of epidemiology at Yale and one of two senior authors , along with Anne Wyllie, an associate research scientist in epidemiology, behind the saliva studies. Consumers drip saliva into a narrow tube. Depending on the proximity of the lab, consumers could get results back within a few hours – and certainly within 24 hours, Grubaugh said.
The Yale test removes one cumbersome and expensive step – the extraction of RNA from samples – which is a core part of nasal swab testing and the Rutgers test. Scientists warned early in the pandemic about supply chain bottlenecks and shortages in equipment needed to extract RNA.
Extraction provides a clearer and more certain result, according to both Brooks and Grubaugh.
“(The Yale test) loses a bit of sensitivity, but what we gain is speed and that it should be up to 10 times cheaper,” Grubaugh said. The Yale test replaces the extraction step with the introduction of a reagent – chemicals mixed with the saliva sample – and a short heating process that releases the virus genome. The team found successful results with reagents that are often available, meaning labs are implementing the Yale protocol everywhere, Grubaugh said. “My goal is not to test athletes,” Grubaugh said. “That’s not my target population. My target population is everyone. There were concerns about cooperating with the NBA when all these other people needed tests. But the simple answer was that the NBA would do all these tests anyway, so why do not partner with them and try to create something for everyone? “
The NBA, Yale and the Players Association do not intend to take royalties on any use of the test method, Grubaugh and others said. The NBA and union contributed more than $ 500,000 to fund the Yale work, sources told ESPN.
Andy Slavitt, the acting administrator of the Centers for Medicare and Medicaid Services during the Obama administration, circulated the Yale results among former FDA commissioners in hopes of guiding it toward a speedy approval for emergency use, he and others said. .
“I helped make sure the right people in the White House were aware of the importance of the test, and the rest took care of themselves,” Slavitt told ESPN’s Adrian Wojnarowski. Slavitt has been part of a working group of virus specialists that includes several sports scientists and the bureau of the NBA League.
“My interest was to help get a scalable test that could become a game-changer across the country,” Slavitt said. “We haven’t got leadership from where we needed it, but it’s great to see the NBA come up.”
The genesis of the Yale-NBA partnership occurred in early April, when Grubaugh and the Yale team published preliminary research indicating that saliva tests performed on coronavirus patients and healthcare professionals were just like nasal swab tests. “That was a critically important paper,” said Martin Burke, a chemistry professor at the University of Illinois whose team developed a similar direct detection test. “It was inspiring for us.”
Illinois is now administering its test to bring back faculty and staff – tens of thousands of people. They aim to test people twice a week, Burke said.
When Yale published its first findings in April, NBA officials and sports scientists throughout the league called labs and scoured literature for possible clues on how to perform quick, inexpensive, and easily accessible tests for players. develop. League leagues and teams were also aware of the criticism they received early in the pandemic for getting tests when they were in short supply and were keen to do so in the broader public interest.
One team official – Robby Sikka, vice president of basketball performance and technology for the Minnesota Timberwolves – came across the Yale paper and emailed Grubaugh.
“We had a lot of strange requests, but this one was at the top,” Grubaugh said. “I saw Timberwolves in the subject line and said, ‘What the hell?'”
The two connected. The investigation quickly reached the office of NBA senior vice president David Weiss, the point guard of the Coronavirus Response Competition – including the formation of the bubble at the Walt Disney World Resort in Orlando.
“A lot of sports leagues and larger organizations thought, ‘OK, we’re shut down, so what can we do?’” Grubaugh said. “‘We’ll have to test our population – players – all the time if we want to play again. How can we do that?’ ‘
The Yale lab did not have its own test at the time; it had previously used existing tests to measure the accuracy of detective tests. Sikka and the league laid the groundwork for the idea of building one, and the NBA and the players’ union offered to fund it.
“I was hesitant,” Grubaugh said. “We’re doing research. We’re not developers of diagnostics. But this was an opportunity. They were willing to fund it. This is a crazy time for everyone. I studied mosquitoes before this.”
With players returning to team markets in April and May, the league called for volunteers to take detective tests – for the purpose of comparing results to the nasal swab tests, the same group would also take. The results showed close universal agreement between tests, according to Yale’s research.
Brooks, the Rutgers professor, expressed some skepticism about the scalability of the Yale / NBA Test. That test still requires labs to buy an expensive molecular testing machine. Labs that administer the test will also be responsible for enormous batches of data collection and storage, Brooks said. He also reiterated that RNA extraction is more accurate.
“I get that everyone wants to do it faster and for a less expensive price, but there also has to be a level of responsibility,” Brooks said.
On the NBA’s campus in Orlando, the league still uses nasal swabs on players, coaches and staff.
The potential for quick-return, cheap and easy-to-manage detective tests could have implications for the structure of the 2020-21 NBA season, sources said. Every return to normalcy – teams traveling to 28 home markets, the presence of even some token number of fans to lose revenue – depends on tests that become readily available. This could be one step, experts said.
Yale and the NBA have already talked to a national lab company about using robotic technology to speed up the processing of tests, sources said. Both parties are interested in the potential of testing pool species – combining samples from different people and testing them together. (Each positive result would then require individual testing.)
“By what miracle this works,” Grubaugh said. “It’s sensitive. It’s cheap. And now it’s getting approval. I’m not quite sure how we got here in April.”
ESPN’s Adrian Wojnarowski contributed to this report.
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