MALVERN, PA — ADVAITE’s RapCov™ Rapid COVID-19 Test, one of the first US manufactured FDA EUA authorized point-of-care (PoC) serology tests, is now available via Amazon Business.
The FDA’s Emergency Use Authorization (EUA) for Advaite’s rapid response IgG antibody test strengthens America’s public health protections against biological threats by facilitating availability and use of cutting-edge medical countermeasures. ADVAITE is one of the only US manufacturers to receive FDA EUA for a point-of-care serology test to date. All RapCov™ Rapid COVID-19 Test Kits are manufactured and assembled locally start to finish at FDA registered facilities in Southeastern Pennsylvania.
“This is a very important moment for public health ain fighting this pandemic,” said Karthik Musunuri, Chief Executive Officer of Advaite. “The ADVAITE RapCov™ Rapid COVID-19 Test offers unique advantages in containing the disease. 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. The inclusion of this test to be made available via Amazon’s online store will allow for expanded accessibility of the test to authorized providers.”
“Fifteen-minute testing can mean peace of mind and workforce readiness,” Musunuri said, adding that another key benefit is that blood specimens do not need to be sent to a laboratory, but rather can be done on the spot at the point of care such as at a physicians office making this an ideal solution for screening mass populations.”
Amazon Business is a global procurement solution now used by more than five million businesses, ranging from sole proprietors to multinational enterprises with tens of thousands of employees on a single account. In the U.S., the two fastest growing customer segments are public entities and enterprises—Amazon Business serves 45 states, 90 of the 100 largest cities and counties, and many other public entities. In addition, more than 80 of the Fortune 100 companies currently use Amazon Business, including Citigroup, Intel, Cisco, and ExxonMobil, as well as 92 of the 100 largest hospital systems.
ADVAITE RapCov™ Rapid COVID-19 Test will help in seroprevalence surveys for determining the prevalence of infection in communities during the COVID-19 pandemic. “The RapCov™ Rapid COVID-19 test uses fingerstick whole blood in point of care settings, therefore this test offers 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 Sandeep Jain, MD, Chief Scientific Officer of Advaite.
ADVAITE Inc. is a Malvern, PA headquartered biotech company focused on developing novel therapeutics and diagnostics to help patients suffering from a variety of debilitating diseases.
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