Vivera Files First of Two US Made COVID-19 Antibody Tests

Vivera Pharmaceuticals has announced the launch of their point-of-care ready rapid serology tests.

Working closely with domestic suppliers, Vivera has now filed an Emergency Use Authorization (EUA) for the first of its two "Made in the USA" serology antibody tests with the FDA. Both are point-of-care tests designed to serve where patients most critically require screening testing. With one test optimized for use in mass-screening settings, such as drive through testing centers, and the other more suitable for use in doctor's offices and health clinics.

"Vivera has undergone clinical trials with nursing homes and health clinics and we have made refinements we feel will best serve the doctors and nurses who will be the ones using the test," said Dr. Stephen McColgan, Vivera Pharmaceuticals' Chief Medical Officer. "Eventually, as the FDA finds the right pathway, we hope to transition into supporting telemedicine providers and expanding the availability of screening testing," he continued.

Once authorized, Vivera's tests would be the first true point-of-care tests designed for convenience and ease of use, allowing providers to triage their patients as efficiently as possible.

"We have been working on a truly U.S. solution to the testing crises. The flood of poorly performing tests – such as the 30 or so removed from the FDA's website – have hurt more than helped," said Paul Edalat, CEO. "In the rush to find an 'answer' many of those responsible for testing gravitated toward cheaper imported options since there were few truly U.S. made tests available."

Vivera's COVx-RT Rapid Test is currently available for use by qualified CLIA laboratories as it awaits final Emergency Use Authorization approval.