Quadrant Biosciences Receives FDA Emergency Authorization for New COVID-19 Saliva Test
SYRACUSE, N.Y., Sept. 23, 2020 /PRNewswire/ -- Quadrant Biosciences Inc., a developer of epigenetic diagnostic tools, announced today that it has received an Emergency Use Authorization (EUA) from the U.S. Food and Drug Administration (FDA) for the Clarifi COVID-19 Test Kit by SUNY Upstate Medical and Quadrant Biosciences ("Clarifi COVID-19 Test"), a saliva-based test to detect nucleic acid from the SARS-CoV-2 virus.
The Clarifi COVID-19 Test, developed in partnership with SUNY Upstate Medical University ("SUNY Upstate"), leverages Quadrant Biosciences' established expertise in RNA-based diagnostics. The non-invasive, and easy to administer, saliva swab test determines the presence or absence of SARS-CoV-2 viral RNA. The Clarifi COVID-19 Test contains a saliva collection swab and the reagents needed to run the analysis, and will be immediately available for use by high-complexity clinical laboratories serving patients through physicians' offices, urgent care clinics and hospitals.
The company designed the Clarifi COVID-19 Test to be patient friendly, clinically useful and efficient for testing laboratories. According to Quadrant Biosciences Founder and CEO Richard Uhlig, one of the key features of the Clarifi COVID-19 test is that it is engineered to limit false-negative results by integrating an RNA stabilizing solution into the saliva collection kit. "This stabilizing solution was designed to prevent RNA degradation prior to laboratory analysis - this is critical as COVID-19 is a single-stranded RNA virus and susceptible to degradation by enzymes in mucus and saliva," Uhlig explains.
SUNY Upstate has partnered with Quadrant Biosciences on this project and, as SUNY Upstate President Dr. Mantosh Dewan explains, it demonstrates the great value of these types of strategic collaborations between academia and industry.
"SUNY 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. 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."
The development of the Clarifi COVID-19 test is also a great example of Quadrant's ability to "nimbly apply its growing expertise in RNA analysis to an urgent healthcare need and expeditiously muster the resources to develop a solution," notes Mr. Uhlig. "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."
About Quadrant Biosciences
Quadrant Biosciences is a life science company developing functional assessments and epigenetic diagnostic solutions for large-scale health issues. The company has entered into collaborative research relationships with a number of institutions including SUNY Upstate Medical University and Penn State University to explore and develop novel biomarker technologies with a focus on Autism Spectrum Disorder, concussion, and Parkinson's disease. Recently, it has leveraged its expertise in RNA analysis to address the Covid-19 pandemic. Quadrant participates in the Start-up NY program, a New York State economic development program. For more information about Quadrant, please visit www.quadrantbiosciences.com.
About Emergency Use Authorization Status
The Clarifi COVID-19 Test Kit has not been FDA cleared or approved. It has been authorized by the FDA under an emergency use authorization for use by authorized laboratories that are certified under the Clinical Laboratory Improvement Amendments of 1988 (CLIA), 42 U.S.C. §263a, and meet requirements to perform high-complexity tests. Clarifi COVID-19 has been authorized only for the detection of nucleic acid from SARS-CoV-2, not for any other viruses or pathogens, and is only authorized for the duration of the declaration that circumstances exist justifying the authorization of emergency use of in vitro diagnostic tests for detection and/or diagnosis of COVID-19 under Section 564(b)(1) of the Act, 21 U.S.C. § 360bbb-3(b)(1), unless the authorization is terminated or revoked sooner.
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SOURCE Quadrant Biosciences Inc.