ADVAITE Receives CE Mark Clearance For Its RapCov™ Rapid COVID-19 Test
MALVERN, PENNSYLVANIA, USA, December 4, 2020
ADVAITE Inc., an innovative biotech company focused on developing novel diagnostic point-of-care tests, announced today it has received CE Mark clearance for its COVID-19 rapid response IgG antibody test, RapCov™, to help efforts to contain the spread of coronavirus infection.
The CE Mark clearance will help strengthen Europe’s public health protections against biological threats by facilitating the availability and use of medical countermeasures, such as the ADVAITE RapCov™ Rapid COVID-19 Test, which are needed during public health emergencies. ADVAITE is committed to supplying the global market with its COVID-19 rapid response diagnostic testing kits. ADVAITE Inc. in partnership with OBELIS S.A as an authorized representative, will begin expansion and marketing efforts immediately.
“We feel the ADVAITE RapCov™ Rapid COVID-19 Test may offer unique advantages in containing the disease. It is simple to use, can provide accurate results from a drop of fingertip blood and detect IgG antibodies to the COVID-19 virus, and show results in 15 minutes,” said Karthik Musunuri, Chief Executive Officer of Advaite. “Further, blood specimens do not need to be sent to a laboratory which makes this an ideal solution for screening mass populations.”
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, we aspire to be just that. Currently, ADVAITE Inc. is focused on developing novel point-of-care assays and deploy them to help combat the modern world’s deadliest disease, COVID-19. With a new 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 point-of-care tests to address this pandemic and help impact large populations. ADVAITE currently markets RapCov™ COVID-19 Rapid Test (http://www.rapcov.com) a lateral flow immunochromatographic assay intended for the presumptive qualitative detection of IgG antibodies to the SARS-CoV-2 in fingerstick whole blood from individuals who are suspected of COVID-19 virus exposure. ADVAITE is also housed within the University of Illinois Incubator Laboratory facility which serves as a home to both life science and engineering firms at various stages of development within a vibrant entrepreneurial ecosystem that leverages University assets and connects Innovation, Infrastructure, Networks, Talent and Capital within and beyond the university.
About the ADVAITE RapCov™ Rapid COVID-19 Test:
The ADVAITE RapCov™ Rapid COVID-19 Test is a lateral flow immunochromatographic assay for the presumptive qualitative detection of IgG antibodies to the COVID-19 virus in human whole blood fingerstick samples. In a US based Point-of-Care clinical study conducted at multiple sites, the RapCov™ Rapid COVID-19 test exhibited 90% sensitivity and 100% specificity on over 100 subjects in regards to the detection of the presence of IgG COVID-19 antibodies in fingerstick whole blood. For more information visit www.rapcov.com
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Director of Commercial Operations, ADVAITE Inc.