FDA issues Emergency Use Authorization for Oral CovAb™ SARS-CoV-2 Ab Test

Diabetomics, Inc., announced the granting of an Emergency Use Authorization (EUA) by the US FDA 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™ 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."