FDA Grants Advaite Emergency Use Authorization FOR RapCov Rapid COVID-19 Test

The U.S. Food and Drug Administration (FDA) has granted Emergency Use Authorization (EUA) to one of the first U.S.-manufactured serology tests designed by ADVAITE.

"This is a watershed moment in the fight against this pandemic," said Karthik Musunuri, Chief Executive Officer of Advaite. "The RapCov™ Rapid COVID-19 Test offers unique advantages in containing the virus. ADVAITE's test is simple to use, provides accurate results from a drop of fingertip blood and can detect IgG antibodies to the COVID-19 virus. Perhaps most critically, our tests provide results in 15 minutes at the point-of-care."

"Fifteen-minute testing can mean peace of mind and workforce readiness," Musunuri said, emphasizing that, "Unlike conventional tests that require offsite blood specimen lab work, the RapCov™ Rapid COVID-19 Test analysis can be done on the spot at the point of care, such as at a physician's office, making this an ideal solution for screening mass populations."

From a public health perspective, the RapCov™ Rapid COVID-19 Test will help in seroprevalence surveys for determining the prevalence of infection in communities during the COVID-19 pandemic.

"Our test uses fingerstick whole blood in point-of-care settings, thereby offering a practical and scalable approach to estimate prevalence of persons who develop SARS-CoV-2 antibodies in a more general population and over repeated time intervals." said Dr. Sandeep Jain, ADVAITE's Chief Scientific Officer.

All RapCov™ Rapid COVID-19 Test Kits are manufactured and assembled start to finish at FDA registered facilities in Southeastern Pennsylvania, and ADVAITE plans to immediately begin supplying the market with its testing kits on a national scale.