BioGX Inc. Gets Emergency FDA Approval for New COVID-19 Test

A Birmingham-based molecular diagnostics company announced on April 3 it has received FDA emergency authorization to produce and distribute a new diagnostic test that will enable hospitals to screen for COVID-19.

BioGX Inc. made the announcement in conjunction with BD (Becton, Dickinson and Co. — NYSE: BDX), a leading global medical technology company.

BioGX’s new test will be run on the BD MAX™ System, a molecular diagnostic platform that BD says is already in use at hundreds of laboratories in nearly every state across the country.

The FDA approval came under its Emergency Use Authorization power.

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BD says its BD MAX™ System can process 24 samples simultaneously and get results in under three hours at hospital-based BD MAX™ Systems, which is where most are located. The tests are expected to add capacity for 50,000 tests per week nationwide.

The assay is based on the same viral RNA targeting sequences and real-time PCR detection method as the test developed by the U.S. Centers for Disease Control and Prevention (CDC), according to the companies’ press release.

BD is one of the largest global medical technology companies in the world and partners with organizations around the world to address some of the most challenging global health issues, including AIDS diagnostic work for the World Health Organization and the Centers for Disease Control.

BioGX Inc., headquartered in Birmingham, and its wholly owned subsidiary BioGX B.V., based in Amsterdam, The Netherlands, (collectively “BioGX”), develop and commercialize molecular diagnostics reagents for diverse applications.

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