Research & Development
Quadrant Biosciences wins FDA's EUA for new saliva swab for Covid-19 testing
24 September 2020 -

Diagnostic tools company Quadrant Biosciences Inc reported on Wednesday the receipt of the Emergency Use Authorization (EUA) from the US Food and Drug Administration (FDA) for the saliva-based Clarifi COVID-19 Test Kit to detect nucleic acid from SARS-CoV-2 virus.

The non-invasive and easy to administer saliva swab test Clarifi COVID-19 Test, developed in partnership with SUNY Upstate Medical University, leverages Quadrant's expertise in RNA-based diagnostics. The test determines presence or absence of SARS-CoV-2 viral RNA.

Effective immediately, the Clarifi COVID-19 Test, which contains a saliva collection swab and the reagents to run the analysis, can be used by high-complexity clinical laboratories serving patients through physicians' offices, urgent care clinics and hospitals, said the company.

According to Quadrant's 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. The Clarifi COVID-19 Test is patient friendly, clinically useful and efficient for testing laboratories.