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FDA GRANTS ADVAITE EMERGENCY USE AUTHORIZATION FOR RapCov™ Rapid COVID-19 Test

January 12, 2021 GMT
(PRNewsfoto/Advaite Inc.)
(PRNewsfoto/Advaite Inc.)

MALVERN, Pa., Jan. 12, 2021 /PRNewswire/ -- The U.S. Food and Drug Administration has granted Emergency Use Authorization (EUA) to one of the first U.S.-manufactured serology tests designed by ADVAITE Inc., an innovative biotech company developing novel point-of-care assays to help with combatting COVID-19.

The federal government’s EUA for ADVAITE’s rapid response IgG antibody test will strengthen America’s public health protections against epidemiological threats by facilitating access to cutting-edge medical countermeasures, such as ADVAITE’S RapCov™ Rapid COVID-19 Test. ADVAITE is one of only a handful of US manufacturers to receive EUA for a point-of-care serology test.

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“This is a watershed moment in the fight against this pandemic,” said Karthik Musunuri, Chief Executive Officer of Advaite. “The RapCov™ Rapid COVID-19 Test offers unique advantages in containing the virus. 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.”

“Fifteen-minute testing can mean peace of mind and workforce readiness,” Musunuri said, emphasizing that, “Unlike conventional tests that require offsite blood specimen lab work, the RapCov™ Rapid COVID-19 Test analysis can be done on the spot at the point of care, such as at a physician’s office, making this an ideal solution for screening mass populations.”

From a public health perspective, the RapCov™ Rapid COVID-19 Test will help in seroprevalence surveys for determining the prevalence of infection in communities during the COVID-19 pandemic. “Our test uses fingerstick whole blood in point-of-care settings, thereby offering 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 Dr. Sandeep Jain, ADVAITE’s Chief Scientific Officer.

All RapCov™ Rapid COVID-19 Test Kits are manufactured and assembled start to finish at FDA registered facilities in Southeastern Pennsylvania, and ADVAITE plans to immediately begin supplying the market with its testing kits on a national scale.

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.

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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 best in-class point-of-care tests to address this pandemic and help impact large populations.

About the 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.

  • 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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SOURCE Advaite Inc.