FDA Authorizes First 45-Minute ‘Rapid Point-Of-Care’ Test

As the number of confirmed cases in New York State and around the country climbs at a staggering rate, and millions of Americans prepare to hunker starting Monday for an economic shutdown that’s set to last for two weeks, the FDA announced Saturday that it has approved a rapid “point-of-care” test for COVID-19 that can produce results for patients within 45 minutes.

The agency approved the test late Friday, and on Saturday announced that it had granted the first approval a California company that will have the tests commercially available by the end of the month (it’s March 21).

The FDA granted “emergency use authorization” to Cepheid, a Cali-based company that makes a rapid molecular test for the coronavirus. Getting results in 45 minutes would be far quicker than the current situation in which tests typically are sent to central reference labs that can take days to deliver results.

The FDA authorization covers “patient care settings” including doctors’ offices, though the tests will reportedly be used mostly in hospitals and ERs, according to the Washington Post.

Most critically, the test doesn’t require a nasal swab (one of many medicinal necessities for which supplies are growing short) and added that a ‘nasal aspirate’ can be used. From what we can tell, that’s a fancy term for a loogie.

In a video on the company’s website, David Persing, Cepheid’s chief medical and technology officer, said the test will “help alleviate the pressure” that the covid-19 has placed on health-care facilities. The new test, he said, will help doctors quickly decide which treatment is appropriate for which patients.

[youtube https://www.youtube.com/watch?v=dRUtUbmPc94]

There’s one other wrinkle: For technicians to run the tests, they will need the company’s automated GeneXpert Systems, of which there are roughly 5,000 in the US, and 23,000 around the world – not exactly a massive supply.

Hopefully, more machines will be available with purchase of the tests. But even if they aren’t, tests currently take 2-3 days for results to become available. Even with these limitations, the new tests will dramatically increase the government’s capacity to test.