SYRACUSE — The COVID-19 test that’s been used for extensive testing of SUNY students now has the go-ahead to for use on a wider scale.
The U.S. Food and Drug Administration (FDA) has granted emergency-use authorization for the individual saliva swab diagnostic test for COVID-19 that SUNY Upstate Medical University and Quadrant Biosciences Inc. developed.
Quadrant Biosciences is based in Syracuse. The company, which was founded in 2015 by CEO Richard Uhlig, says it “works with top academic institutions, medical researchers and engineers to translate breakthrough findings scientifically sound epigenetic diagnostic tools.” These tools are part of the growing Clarifi diagnostic platform and address a number of neurological-health challenges.
So far, this test has been used to support SUNY’s widespread testing of students across campuses, but the emergency-use authorization will help additional labs begin to use this test, “helping pinpoint and contain” the virus and protect New Yorkers, the office of Gov. Andrew Cuomo said.
In August, the New York State Department of Health granted approval for SUNY Upstate Medical University to use the test for surveillance testing purposes in the SUNY student body. With the FDA authorization, this new 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.
FDA approval of this “game-changing” COVID-19 test demonstrates the “ingenuity of the State University of New York to solve pressing issues,” SUNY Chancellor Jim Malatras contended in a statement.
“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,” Malatras said.
The FDA-authorized saliva test for individuals complements Upstate Medical’s and Quadrant’s pool testing, which allows for about 10 to 25 people to be screened in one COVID-19 test. The FDA’s approval of the test 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.
“This is indeed a game-changer,” Dr. Mantosh Dewan, interim president of SUNY Upstate Medical University, said. “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.”