Becton Dickinson (NYSE:BDX) announced today that it received FDA emergency use authorization (EUA) and CE Mark approval for a new COVID-19 molecular diagnostic test.
The test, based on the U.S. Centers for Disease Control assay design and run on the BD Max system, may return results in 2-3 hours, according to the Franklin Lakes, N.J.-based company. It adds to the portfolio of tests already available on the BD Max system from collaborations with BioGX and CerTest.
BD Max is already in use at thousands of laboratories across the world, according to a news release. Each unit is capable of analyzing hundreds of samples in 24 hours. The fully automated system can process 24 samples simultaneously, the company noted.
“The new BD COVID-19 test for the BD Max System will help increase availability of these much-needed tests around the world,” BD president of integrated diagnostics Dave Hickey said in a news release. “We continue to work toward a full portfolio of testing options to give healthcare workers choice and access to the right test for the right situation.”
BD said it will make the test available in the U.S. and in European countries that recognize CE Mark approval.