A saliva-based diagnostic test developed by researchers at SUNY Upstate Medical University and Quadrant Biosciences, a Start Up NY company based on the Upstate campus in Syracuse, N.Y., to detect whether an individual is infected with COVID-19 has been granted emergency use authorization by the U.S. Food and Drug Administration.

The announcement of the FDA's action was made Sept. 23 by New York Gov. Andrew Cuomo and State University of New York Chancellor Jim Malatras. 

“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,” 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.”

The Clarifi COVID-19 test is a non-invasive and easy to administer saliva swab that determines the presence or absence of SARS-CoV-2 viral RNA. The Clarifi COVID-19 Test Kit contains the saliva collection swab and the reagents needed to run the analysis.

The emergency use authorization by the FDA means the test is now widely and available immediately for use by high-complexity clinical laboratories serving patients through physicians' offices, urgent care clinics and hospitals.

“This is indeed a game-changer,” said SUNY Upstate Medical University Interim President Mantosh Dewan, MD. “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, applauded the move by the FDA. “We are thrilled that the FDA has issued the Clarifi COVID-19 Test EUA approval for use in the diagnosis of COVID-19,” he said. “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.”

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,”

Malatras continued, “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.”

New York state approved the use of the Upstate/Quadrant test last month and it has been used in coordination with Upstate’s pooled saliva surveillance testing. The combination of surveillance pool testing and the saliva diagnostic testing enables rapid screening of more than 15,000 samples a day in a single lab, followed by clinical testing of positive pools without the need to collect a new sample. 

The unique nature of the collection kits is that it inactivates antiviruses that might be present in the saliva, while stabilizing it for diagnostic testing at a remote facility. 

Dewan thanked all those involved in getting to this breakthrough announcement. “Everyone from medical technologists to our SUNY colleagues and federal lawmakers supported Upstate and Quadrant Biosciences at every turn as we harnessed our scientific prowess on all fronts to develop this important COVID-19 diagnostic test,” he said.

Dewan noted that this breakthrough work on COVID-19 is just the most recent collaborative success with Quadrant Biosciences, a Start Up NY firm with a long-standing presence on the Upstate campus.

“Upstate’s work with Quadrant Biosciences, a Start-Up New York company, has led to important breakthroughs in the development of saliva-based diagnostic solutions for neurological conditions such as autism spectrum disorder, Parkinson's disease and concussion injuries,” Dewan said. “The ability to transfer this innovative approach to address the exigent need for COVID-19 testing solutions, further demonstrates the critical importance of these types of collaborations.” 

U.S. Sen. Charles Schumer applauded the announcement. “As New York rebuilds and recovers from this unprecedented health and economic crisis, an aggressive testing strategy is needed to keep the virus at bay. With FDA authorization for its rapid COVID test, SUNY Upstate will now play a lead role in that strategy,” Schumer said. “I am proud of SUNY Upstate and will continue to fight for a fully-funded testing strategy that keeps New Yorkers safe.”

U.S. Rep John Katko said the decision will greatly expand testing capability. “It’s incredible news that SUNY Upstate Medical University and Quadrant Biosciences has been granted FDA authorization for this ground-breaking test, which will significantly expand and enhance testing capabilities throughout Central New York and across the state. As our nation works to combat the COVID-19 pandemic, it is critical that we continue to promote and implement innovative solutions like those offered by SUNY Upstate.”

Caption: Upstate's Frank Middleton, PhD, left, one of the developers of the saliva-based COVID-19 diagnostic test, speaks with SUNY Chancellor Jim Malatras during a recent visit to the Upstate campus about how the test is being used on SUNY campuses across the state.