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Coronavirus company news summary – OraSure seeks FDA approval for Covid-19 rapid antigen test – BD gets FDA approval for combination Covid-19, flu rapid antigen test

31 Mar 2021 (Last Updated March 31st, 2021 14:51)

OraSure Technologies has submitted an application to the US Food and Drug Administration (FDA) for Emergency Use Authorization (EUA) of its Covid-19 rapid antigen test. The EUA would allow for the test to be used as an at-home prescription test, as well as for professional use in point-of-care (POC) settings. OraSure has started manufacturing the assay test alongside the EUA submission.

BD has received EUA from the FDA for its new, rapid antigen test that can detect SARS-CoV-2, influenza A and B in one sample. The BD Veritor System delivers results within 15 minutes and is expected to launch the test in the summer of 2021-2022.

Olive Labs and Concentric by Ginkgo are working together to provide a simple and accessible testing modality for Covid-19-pooled testing, targeting US schools operating hybrid or in-person learning. Concentric runs testing across 15 states, with more than 800 schools signed up for its affordable testing programme.