FDA permits marketing of first SARS-CoV-2 diagnostic test through premarket review process

The FDA announced that it granted marketing authorization to BioFire Diagnostics for its SARS-CoV-2 (COVID-19) test.

Although the test already had emergency use authorization (EUA), the new marketing authorization was granted through the De Novo premarket review pathway, marking the first SARS-CoV-2 diagnostic permitted to be marketed beyond the public health emergency, according to an FDA release.

“Today’s action is a great demonstration of the FDA’s work to protect the public health in emergency response situations and beyond,” FDA Acting Commissioner Dr. Janet Woodcock said in the release. “We ensured there were tests made available quickly under EUA; and we continue to work with diagnostic manufacturers to take the next step of ensuring products are FDA reviewed for safety and effectiveness and authorized for marketing under our traditional premarket authorities.

“While this is the first marketing authorization for a diagnostic test using a tra…

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DoD paying Biomérieux subsidiary $3.1M to boost COVID-19 test production

The U.S. government announced that it signed a $3.1 million agreement with Biomérieux subsidiary BioFire to expand production of its COVID-19 test.

Government funding came from the U.S. Defense Dept. (DoD), in coordination with the Dept. of Health and Human Services (HHS), according to a news release.

BioFire’s COVID-19 test received FDA emergency use authorization (EUA) in March. The $3.1 million investment from the government will allow the company to increase its manufacturing capacity by expanding its facility in Salt Lake City with two new production lines.

The company is set to triple its manufacturing capacity for tests, beginning in September 2020. Those tests are compatible for use with BioFire’s FilmArray instruments that are, according to a news release, fielded across the DoD and Department of State.

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