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Venerdì 22 Gennaio 2021
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ADVAITE Receives CE Mark Clearance For Its RapCov™ Rapid COVID-19 Test

04 dicembre 2020 | 17.36
LETTURA: 2 minuti

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.

(PRNewsfoto/Advaite Inc.)

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.

Contacts

For Sales Inquires Brahma Prathi Director of Commercial Operations, Advaite Inc. bprathi@advaite.com  

European Authorized RepresentativeOBELIS S.A. Bd Général Wahis, 53 B-1030 BrusselsBelgiumTel: +3227325954 Fax: +3227326003 mail@obelis.net

Logo - https://mma.prnewswire.com/media/1123428/Advaite_Logo.jpg  

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