FDA issues Emergency Use Authorization for CovAb™ SARS-CoV-2 Ab Test, the oral fluid rapid test for SARS-CoV-2 antibodies

CovAb, the only oral fluid rapid, Pan Ig antibody test for Covid-19 gets FDA Emergency Use Authorization

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Provider: 
PR NewswirePR Newswire
Retrieved on: 
Thursday, June 24, 2021
Information
Tags: 
Medicine, Health sciences, Medical specialties, Antiviral drugs, COVID-19 drug development, Monoclonal antibodies, COVID-19, Public health, Zoonoses, Emergency Use Authorization, Development of COVID-19 tests, Viral disease testing
Geotags: 
Oregon, US, ORE
Organisation: 
DIABETOMICS
Website: 
http://www.diabetomics.com
Summary
Key Points: 
  • CovAb, the only oral fluid rapid, Pan Ig antibody test for Covid-19 gets FDA Emergency Use Authorization
    CovAb is the first and only rapid, oral fluid-based, point-of-care antibody test authorized by the FDA for use under an EUA.
  • In addition to being rapid and noninvasive, the CovAb test has sensitivity of 97.6% and specificity of 98.8%.
  • The CovAb test was developed based on Diabetomics' expertise in oral fluid and autoantibody diagnostics developed for its core service areas of diabetes and fetal-maternal disease.
  • The CovAb test is available for sale through Diabetomics' subsidiary COVYDx, Inc.
    View original content to download multimedia: http://www.prnewswire.com/news-releases/fda-issues-emergency-use-authori...


FDA issues Emergency Use Authorization for CovAb™ SARS-CoV-2 Ab Test, the oral fluid rapid test for SARS-CoV-2 antibodies

HILLSBORO, Ore., June 24, 2021 /PRNewswire/ -- Diabetomics, Inc., today announced the granting of an Emergency Use Authorization (EUA) by the US Food and Drug Administration for the Company's CovAb™ SARS-CoV-2 Ab point-of-care test. The product had also received a CE mark for marketing in the EU earlier.

CovAb™, the only oral fluid rapid, Pan Ig antibody test for Covid-19 gets FDA Emergency Use Authorization

CovAb™ is the first and only rapid, oral fluid-based, point-of-care antibody test authorized by the FDA for use under an EUA. Unlike other COVID-19 antibody tests that require a blood draw, the CovAb™ test only requires an oral fluid sample obtained with a simple swab of the gumline, making it easy and painless. The test is CLIA-waived, is all-inclusive, does not require any additional components or instrumentation, and test results are available within 15 minutes.

In addition to being rapid and noninvasive, the CovAb™ test has sensitivity of 97.6% and specificity of 98.8%.

The CovAb™ test was developed and is manufactured in the US.

"We are excited to bring this revolutionary new COVID-19 antibody test to market, which offers an easy and quick testing option to determine antibody status," said Srinivasa Nagalla, M.D., Diabetomics CEO. "The CovAb™ test can be easily administered to adults and children with no discomfort and provides quick results."

For further information, please visit our website at https://Covab.com/

About Diabetomics
Diabetomics, Inc., is a global medical diagnostics company pioneering innovative, noninvasive, point-of-care tests. The company's mission is to advance the health and wellbeing of patients through simple, cost-effective, and easily accessible diagnostic technologies. The CovAb™ test was developed based on Diabetomics' expertise in oral fluid and autoantibody diagnostics developed for its core service areas of diabetes and fetal-maternal disease. The CovAb™ test is available for sale through Diabetomics' subsidiary COVYDx, Inc.

Cision View original content to download multimedia:http://www.prnewswire.com/news-releases/fda-issues-emergency-use-authorization-for-covab-sars-cov-2-ab-test-the-oral-fluid-rapid-test-for-sars-cov-2-antibodies-301318887.html

SOURCE Diabetomics

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