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FDA Issues Emergency Use Authorization To Becton, Dickinson's Covid-19 Antigen Test

fdaaprovedim sep19 07jul20 lt

The U.S. Food and Drug Administration issued Emergency Use Authorization (EUA) for a new rapid, SARS-CoV-2 antigen diagnostic test. This test can be administered at the point of care that will deliver results within 15 minutes.

Developed by Becton, Dickinson and Co. (BDX), the new SARS-CoV-2 diagnostic test is approved for use in authorized laboratories using the company's BD Veritor plus System, an easy-to-use, portable device, which is currently in use at more than 25,000 hospitals, clinician offices, urgent care centers and retail pharmacies in the U.S.

BD plans to begin shipping the new test this week and increase the capacity to 2 million tests per week by the end of September. The company expects to produce up to 10 million tests from July through September.

"Antigen tests play an important role in the overall response against COVID-19, including as a point-of-care test that can potentially scale up to test millions of Americans quickly," said FDA Commissioner Stephen M. Hahn, M.D.

This is the company's third diagnostic test to receive Emergency Use Authorization by the FDA for detecting COVID-19.

Monday BD stock was up $5.52 or 2.25% before closing at $250.47.

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