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Early FDA Approval to Speed Up Coronavirus Testing

By Cory Renauer - Mar 22, 2020 at 6:43AM

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The FDA has approved the first coronavirus test that quickly provides results on site.

On Saturday, Danaher (DHR -1.12%) received an emergency use authorization for its on-site coronavirus test from the U.S. Food and Drug Administration (FDA). Unlike tests that are sent away to a centralized lab, the Xpert Xpress SARS-CoV-2 test can check a sample for the virus that causes COVID-19 in about 45 minutes.

Less centralized

Hundreds of thousands of Americans who have sent their samples to coronavirus testing laboratories spend days, sometimes more than a week, waiting for results. That's because laboratories that process those samples can only handle so many at once.

A COVID-19 test sample.

Image source: Getty Images.

The FDA issued Cephid, Danaher's molecular diagnostics subsidiary, an emergency use authorization that will go a long way to reduce the backlog. There are around 5,000 of Danaher's GeneXpert Systems in hospitals across the U.S., and just about anyone can use them to run the Xpert Xpress SARS-CoV-2 test. 

Cephid's GeneXpert Systems are designed to be run by medical staff without any special training, and the machines can run around the clock.

Is it working?

There have been at least 24,000 confirmed cases of COVID-19 in the U.S., and this number will probably rocket once every high-risk patient who submitted a sample finally has results. The social distancing precautions that are halting entertainment and restaurant businesses might be enough to flatten the curve and prevent millions of untimely deaths, but we won't know until we can get more eyes on problem. 

We should start getting a better look at the numbers soon. According to Danaher, the new tests will go out next week. 

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