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

[video src="https://mma.prnewswire.com/media/1550269/CovAb__15_second_video.mp4" poster="https://www.polandnewstoday.com/wp-content/uploads/2021/06/fda-issues-emergency-use-authorization-for-covab-sars-cov-2-ab-test-the-oral-fluid-rapid-test-for-sars-cov-2-antibodies.jpg"] HILLSBORO, Ore., June 24, 2021 /PRNewswire/ — Diabetomics, Inc., today announced the granting of an Emergency Use Authorization (EUA)…

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.

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SOURCE Diabetomics