MALVERN, PA — The U.S. Food and Drug Administration has granted Emergency Use Authorization (EUA) to one of the first U.S.-manufactured serology tests designed by ADVAITE Inc., an innovative biotech company developing novel point-of-care assays to help with combatting COVID-19.
The federal government’s EUA for ADVAITE’s rapid response IgG antibody test will strengthen America’s public health protections against epidemiological threats by facilitating access to cutting-edge medical countermeasures, such as ADVAITE’S RapCov™ Rapid COVID-19 Test. ADVAITE is one of only a handful of US manufacturers to receive EUA for a point-of-care serology test.
“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.
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