ADVAITE Now Offers FDA EUA RapCov™ Rapid COVID-19 Tests Through Amazon Business
MALVERN, PENNSYLVANIA, USA, March 18, 2021
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 in 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.
About ADVAITE Inc.
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. The word ‘Advaite’ means ‘one without a second’, unrivaled or unique. At ADVAITE, our Team aspires to be just that.
Currently, ADVAITE Inc. is focused on developing novel point-of-care assays to help combat the modern world’s deadliest disease, COVID-19. With a high complexity CLIA laboratory based in Chicago, Illinois and an expanded state-of the-art R&D facility in Malvern, PA; ADVAITE is continuously innovating, developing and commercializing best in-class point-of-care tests to address this pandemic and help impact large populations.
About the ADVAITE RapCov™ Rapid COVID-19 Test
The ADVAITE RapCov™ Rapid COVID-19 Test is a lateral flow immunochromatographic assay for the qualitative detection of IgG antibodies to SARS-CoV-2 in human fingerstick whole blood specimens. Testing of fingerstick whole blood specimens is limited to laboratories certified under CLIA, that meet the requirements to perform high, moderate or waived complexity tests. Testing of fingerstick whole blood specimens is authorized for use at the POC, i.e., in patient care settings operating under a CLIA Certificate of Waiver, Certificate of Compliance, or Certificate of Accreditation. At this time, it is unknown for how long antibodies persist following infection and if the presence of antibodies confers protective immunity. Visit http://www.rapcov.com for more information.
- This test has not been FDA cleared or approved, but has been authorized for emergency use by FDA under an EUA for use by authorized laboratories;
- This test has been authorized only for detecting the presence of IgG antibodies against SARS-CoV-2, not for any other viruses or pathogens; and
- The emergency use of this test is only authorized for the duration of the declaration that circumstances exist justifying the authorization of emergency use of in vitro diagnostics for detection and/or diagnosis of COVID-19 under Section 564(b)(1) of the Federal Food, Drug and Cosmetic Act, 21 U.S.C. § 360bbb3(b)(1), unless the declaration is terminated or authorization is revoked sooner.
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