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BD, BioGX Get EUA From FDA For New 3 Hr COVID-19 Screening Test - Quick Facts

Medical technology company Becton, Dickinson and Co. or BD (BDX) and molecular diagnostics company BioGX Inc. announced Friday that the U.S. Food and Drug Administration (FDA) has granted Emergency Use Authorization (EUA) for a new diagnostic test that will enable hospitals to screen for coronavirus (COVID-19) on site and get results in under three hours.

The test will be run on the BD MAX System, a molecular diagnostic platform, already in use at hundreds of laboratories in nearly every state across the country. Each unit is capable of analyzing hundreds of samples per day, with facility to process 24 samples simultaneously.

BioGX developed the assay for the BD MAX System in their Sample-Ready ready-to-use format to detect the presence of the SARS-CoV-2 virus, the cause of COVID-19. 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).

The BioGX SARS-CoV-2 Reagents for the BD MAX System has not been cleared or approved by FDA. However, it has been authorized by the FDA under an EUA. The test has been authorized only for the detection of RNA from SARS-CoV-2 virus and not for any other viruses or pathogens.

The majority of BD MAX Systems are installed in hospital laboratories, reducing the added time and complexity of needing to send samples to a reference lab.

The companies said the new test will be immediately available to increase capacity of rapid, on-site testing of COVID-19 at hospitals across the U.S. The test helps fill an urgent need across the U.S. for hospitals. The tests are expected to add capacity for 50,000 tests per week nationwide.

BD added that it continues to work diligently on an antigen test for our point-of-care BD Veritor System that would complete a full portfolio of COVID-19 tests.

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