Test that detects coronavirus, flu gets FDA emergency use authorization, company says

The medical technology company behind a molecular diagnostic test that can detect both the influenza virus and coronavirus in a little as two to three hours said it received Emergency Use Authorization from the FDA on Friday.

Becton, Dickinson and Company (BD), said its test, which runs on the company’s existing BD Max platform, is also capable of detecting the U.K. and South African coronavirus variants with 99.9% accuracy.  

“A computer analysis showed that 99.9% of the genetic sequences of these variants are an identical match to at least one of the two molecular targets for the test,” the company said in a news release. “This ability to detect these new variants also applies to the standalone SARS-CoV-2 test for the BD Max System.”

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The test, which also detects influenza A and B strains, provides a positive or negative result for each virus using a single specimen. The company said thousands of laboratories worldwide are already using the BD Max System diagnostic platform, and that each unit is able to analyze hundreds of samples over a 24-hour period.

“Our diagnostic solutions for COVID-19 and Flu will help inform timely diagnosis and, ultimately, may contribute to faster and clinically appropriate patient management and treatment,” said Dave Hickey, president of Life Sciences for BD, in a news release. “In addition, the new information provided on the test’s ability to detect the U.K. and South African variants provides helpful guidance to health care practitioners as we look to identify and contain these new strains.”

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The company said it also received a CE mark, which indicates approval in the European Union.