BARDA, InBios partner to develop serological COVID-19 tests

The Biomedical Advanced Research and Development Authority (BARDA) and Seattle-based InBios International, Inc. are collaborating on the rapid development of a point-of-care assay (test) to detect SARS-CoV-2 reactive antibodies in a blood samples.

The SCoV-2 Ab Detect™ Rapid Test will be a lateral flow “serodiagnostic” test, using blood products (including blood from a finger prick) to identify people infected with SARS-CoV-2, the virus that causes COVID-19 disease. By looking for an immune response to the virus, serology tests help healthcare providers and public health officials better quantify the number of cases of COVID-19 in the country, including among people who may not show symptoms or who have recovered.

In order to make the test more widely available, the company will acquire reagents, including patient samples, and will produce kits for and carry out performance studies to validate the assay design; these steps are needed to request Emergency Use Authorization (EUA) from the U.S. Food and Drug Administration (FDA). Making these tests available would increase U.S. testing capacity and help combat the current pandemic.

An EUA submission package will follow the FDA pre-EUA template and will include a proposed intended use statement, study performance data, and a draft package insert. A final EUA package submission is expected within six months of this award.

Read more: https://www.medicalcountermeasures.gov/newsroom/2020/inbios-diagnostic/