Governor congratulates SUNY Upstate Medical on No. 1 FDA ranking among COVID-19 saliva test for detecting virus in earliest stages
Gov. Andrew M. Cuomo congratulated SUNY Upstate Medical today on its number one ranking COVID-19 saliva test by the U.S. Food and Drug Administration for detecting the virus in its earliest stages. The test developed by Upstate Medical and NY Start-Up Quadrant Biosciences, called Clarifi COVID-19, was also cited by the FDA as being among the most sensitive tests regardless of type, ranking 6th worldwide in detecting the virus. The test is cost effective and easy to use, which Cuomo credits for helping SUNY campuses pinpoint cases at the earliest stages of the virus.
"New York's medical experts are second to none and from the very beginning of this pandemic, we have relied on their vast knowledge and expertise to inform our response," Cuomo said. "This crucial development and expertise has played a critical role in ensuring SUNY students were tested efficiently and, if positive, isolated and on a path to recovery sooner. On behalf of the family of New York, I thank SUNY Upstate Medical, Quadrant Biosciences and Dr. Frank Middleton for their diligence and steadfast commitment to fighting this invisible enemy."
The FDA reviews COVID-19 tests based on the effectiveness of finding the smallest traces of SARS-CoV-2, the virus which causes COVID-19. The Upstate Medical and Quadrant Biosciences Clarifi COVID-19 Test falls into the saliva testing category and has the best (lowest) Limit of Detection at 600 copies of the virus per milliter. Tests with lower LoDs are better able to detect infections at the earliest stages when individuals may be infectious, but asymptomatic. The Clarifi COVID-19 test is among the most sensitive in any category—only five others are more so currently.
SUNY Chancellor Jim Malatras said, "Upstate Medical's and Quadrant Biosciences' saliva test is significant for SUNY—not only fast and easy to use with results back within 48 hours, but also the test itself finds the virus within the earliest stages of the illness, so we can know who is positive more quickly and ensure they isolate from others. While 2020 has certainly been a trying year, it has also reminded us of the critical expertise we have within our public higher education system to provide an excellent education, as well as solutions to the most complex issues facing our society. My congratulations to Upstate Medical, in particular Dr. Dewan and lead researcher Dr. Frank Middleton, and Rich Uhlig and his team at Quadrant Biosciences."
Upstate Medical President Mantosh Dewan said, "The recent FDA report that shows the Clarifi COVID-19 saliva test by SUNY Upstate Medical University and Quadrant Biosciences (Quadrant Biosciences Clarifi COVID-19 test) as the top-rated saliva test, with a sensitivity rate that is one of the best in the world for the detection of COVID is a remarkable accomplishment. Our work on this important life-saving test with Quadrant Biosciences—our Start UP New York business partner—is a ringing endorsement of the excellence that can come from partnerships with industry and public academia."
Quadrant Biosciences CEO Richard Uhlig said, "Increasingly, the medical community is recognizing that tests with better sensitivity are critical to limit the spread of SARS-CoV-2. The FDA recently published results from their unbiased analysis of all FDA authorized tests - we're pleased to see the Clarifi COVID-19 Test listed as the #1 saliva test and among the most sensitive tests available anywhere in the world."
The Clarifi COVID-19 test by Upstate Medical and Quadrant Biosciences has been used throughout the fall semester on SUNY campuses for regular, mandatory testing of students, faculty, and staff. To date, SUNY has conducted 580,805 tests this fall with a positive rate of 0.52 percent. Upstate Medical has the capacity currently to conduct 200,000 tests per week. SUNY, Upstate Medical, and Albany International Airport recently announced a partnership to test airport employees starting on Friday, December 11, and passengers later this month.
About SUNY Upstate Medical's Pooled Surveillance Testing
SUNY has been able to conduct more than 200,000 tests weekly this semester thanks to a series of major breakthroughs at SUNY Upstate Medical. Both the New York State Department of Health and FDA gave approval for an individual saliva swab test developed by Upstate Medical and Quadrant Biosciences. By combining this groundbreaking individual saliva swab test with Upstate Medical's state-approved pooled testing protocol.
Both the individual test and the pooled test developed by Upstate Medical and Quadrant can be done using saliva swabs rather than by swabs inserted in a person's nose.
Individuals administer the tests themselves, swabbing their mouths and provide the saliva samples to Upstate Medical. Their samples are combined into one, which is tested for COVID 19 virus.
A negative test means that all 10-25 people in the group are presumed at the time to be coronavirus-free.
A positive test for the pool would mean each individual saliva sample within the pool would need to be tested again individually to pinpoint exact positive cases. The rapid retesting does not require people in the positive pool to return to submit an entirely new sample. This greatly accelerates the process and expands testing capacity.
Caption: Upstate's Frank Middleton, PhD, explains how the saliva swab test has been used in pool testing to keep SUNY and other colleges safe.