BD Rapid Coronavirus Test Gets FDA Emergency Use Authorization, Promises Results In 15 Minutes

Becton, Dickinson and Co. (BDX), one of the largest medical technology companies in the world, announced Monday the Food and Drug Administration had issued an emergency use authorization for a rapid, point-of-care coronavirus test, which the company said can deliver results in 15 minutes.

Such tests have been deemed necessary for controlling the COVID-19 pandemic, which had killed more than 130,000 Americans as of noon Monday.

The authorization was issued for an immunoassay test that works with BD’s Veritor Plus System, which is slightly larger than a cellphone and currently is in use at more than 25,000 hospitals, doctors’ offices, urgent care facilities and drug stores across the country, the company said.

BD said it hopes to produce 2 million tests a week by the end of September.

"This will be a game-changer for frontline healthcare workers and their patients to be able to access a quick diagnostic test for COVID-19, offering results in real-time at convenient locations like retail pharmacies, urgent care centers and doctors' offices," Dave Hickey, president of integrated diagnostic solutions for BD, said in a press release.

"Such tests will also help communities be more informed and better prepared to help prevent new spikes and additional waves of COVID-19 by enabling public health workers to quickly identify infectious individuals and trace their contacts.”

BD said it had tested the system at more than 20 sites and obtained 84% sensitivity and 100% specificity, putting it on a par with tests for such ailments as flu and strep. Negative results are to be confirmed by further testing on the molecular level.

Adm. Brett Giroir, assistant secretary for health, said the BD test "will significantly expand testing."

He said it will help protect at-risk populations that have been particularly vulnerable to the pandemic.

The FDA earlier in March authorized use of the Cepheid Xpert Xpress COVID-19 test, which delivers results within hours rather than the days it took earlier tests.

The Abbott ID NOW test also was authorized in March, and the FDA authorized its continued use in May as it investigated reports of inaccuracies to determine whether the types of swabs used or the way the samples were transported were responsible.

Becton, Dickinson was trading 3.21% higher at $252.99 shortly after noon EDT.