Company's diagnostic testing kit "RapCovTM" offers the promise of a convenient and rapid solution for screening large populations for IgG antibodies to COVID-19
MALVERN, Penn., Dec. 4, 2020 /PRNewswire/ -- 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."
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, we aspire 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 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.
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 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.
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