FDA Approval Enables Test – Currently Used to Test on All SUNY Campuses – to Be Brought to Greater Scale Statewide
ALBANY, NY — Governor Andrew M. Cuomo and State University of New York Chancellor Jim Malatras today announced that the individual saliva swab diagnostic test for COVID-19 developed by SUNY Upstate Medical University and Quadrant Biosciences has been granted emergency use authorization by the U.S. Food and Drug Administration. While this test has been used to date to support SUNY’s widespread testing of students across campuses, the emergency use authorization will help additional labs begin to use this test, helping pinpoint and contain the virus and protect New Yorkers.
“From the beginning of the COVID-19 crisis, it’s been clear that testing is one of the most critical tools we have to slow the spread. The more you test, the more accurate a picture of the state’s cases you have,” Governor Cuomo said. “This is a perfect example of how New York’s approach of partnering state institutions with the private sector is paying dividends and helping us fight the pandemic. I want to thank SUNY’s talented team that produced this simple, quick and effective solution to conduct more testing, faster. We’re glad to see it approved by the FDA and look forward to its use throughout New York and beyond.”
State University of New York Chancellor Jim Malatras said, “FDA approval of this game-changing COVID-19 test demonstrates the ingenuity of the State University of New York to solve pressing issues. With this approval the innovation developed by Upstate Medical and Quadrant Biosciences will be leveraged on a national scale. This quick, noninvasive testing protocol—which has already boosted SUNY’s testing capacity to 120,000 tests per week—will now help communities across the country better pinpoint and contain COVID-19. It’s further proof that New York State continues to lead the way in the fight against this vicious virus. I want to thank Governor Cuomo for his unwavering support by fostering public-private partnerships and his continued investment in innovation on our SUNY campuses—both of which helped make this possible.”
SUNY Upstate Medical University Interim President Dr. Mantosh Dewan said, “This is indeed a game-changer. We have seen the benefits of this testing here in New York state as we have used it to test significant numbers of individuals quickly and safely to keep our communities, and in the case of our current testing work, local school districts and college campuses safe.”
Richard Uhlig, Quadrant Biosciences founder and CEO, said “We are thrilled that the FDA has issued the Clarifi COVID-19 Test EUA approval for use in the diagnosis of COVID-19. The coronavirus has had a devastating effect on health and welfare worldwide, so it is extremely gratifying for us to take the expertise we have gained working on RNA diagnostic tests for other health conditions, such as autism spectrum disorder and Parkinson’s disease, and apply that expertise to the development of this critically important test.”
The FDA-authorized saliva test for individuals complements Upstate Medical’s and Quadrant’s innovative pool testing, which allows for about 10 to 25 people to be screened in one COVID-19 test. The test’s approval by the FDA means it can be brought to scale across New York State as well as used nationwide.
The approved tests can be conducted using saliva swabs rather than swabs inserted in a person’s nose. Individuals administer the tests themselves, swabbing their mouths, and provide the saliva samples, which are currently processed at SUNY Upstate Medical Center’s laboratory.
In August, the New York State Department of Health granted approval for the test to be used by SUNY Upstate for surveillance testing purposes in the SUNY student body. With today’s FDA authorization, this new, innovative test will now be available for use throughout the State of New York and the U.S. by high-complexity clinical laboratories serving patients at physicians’ offices, urgent care clinics and hospitals.
The saliva test has been successfully developed by SUNY Upstate and Quadrant into a “pooled test” where multiple samples are combined into a single “pooled” sample, which is tested for COVID-19. If the entire pooled sample tests negative, this means that all 10 to 25 people whose individual samples are included in the pooled group are presumed at the time to be COVID-free. Prior to DOH and FDA approval, if a pooled sample tested positive, each individual had to be retested. Now, thanks to this innovation by SUNY Upstate and Quadrant, if the pooled sample tests positive, each individual saliva sample within the pool is quickly tested individually to pinpoint exact positive cases and can occur without the need to collect a new sample, thus providing the ability to rapidly screen more than 15,000 samples a day in a single lab to identify the infected individuals. The combination of surveillance testing and follow-up individual diagnostic testing, all using saliva samples and pooled technology, is a cutting-edge innovation that has enabled SUNY Upstate and Quadrant to provide affordable, high quantity testing across the entire SUNY system.