First True POC COVID-19 Antibody Tests Offer Convenience and Ease of Use

Two newly-launched rapid COVID-19 antibody tests are awaiting Emergency Use Authorization (EUA) approval from the US FDA and once authorized, would become the first true point-of-care (POC) tests designed for convenience and ease of use, allowing providers to triage their patients as efficiently as possible.

Vivera Pharmaceuticals, Inc. (Newport Beach, CA, USA) has launched the POC ready rapid serology tests which are designed to serve where patients most critically require screening testing. One test is optimized for use in mass-screening settings, such as drive through testing centers, and the other test is more suitable for use in doctor's offices and health clinics. Following in the footsteps of its first EUA filing, Vivera is voluntarily taking part in the National Cancer Institute backed validation studies for its two new filings. Vivera plans to use its serology antibody tests to begin its forthcoming clinical trials in support of eventual medical device filings with the FDA as the company further expands its advanced diagnostics division.


"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," stated 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."


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