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Cepheid wins 1st FDA nod for point-of-care coronavirus test

Sunnyvale, California-based molecular diagnostics company Cepheid is the first manufacturer to win FDA emergency use authorization for a point-of-care test for the novel coronavirus.

The agency said in its announcement Saturday the company planned to roll out the test for use in hospitals by March 30.

The test, run on Cepheid's GeneXpert systems, takes about 45 minutes to deliver results. The company said there are nearly 5,000 of the automated systems currently deployed throughout the U.S., with more than 23,000 around the world.

With point-of-care testing, FDA Commissioner Stephen Hahn said in a statement on Saturday ​results will be delivered to patients in "hospitals, urgent care centers and emergency rooms, instead of samples being sent to a laboratory" and will enable "patient access to more immediate results.” 

While tests from clinical lab networks LabCorp and Quest have significantly increased the nation's coronavirus testing capacity in recent weeks, those services require a healthcare provider to send specimens to an external facility. In addition, patients with a suspected case of COVID-19 do not receive confirmed results for at least a few days.

President Donald Trump sees the Cepheid test as a potential "game changer" for ramping up the nation's COVID-19 testing capacity. Trump said at Sunday's White House press briefing: "If this works out, and we think it might, the new test will be a very simple one, much easier than the existing tests which are quite complex."​

Another potential advantage of Cepheid's 45-minute test is that it can use a saline wash for testing if swabs are not available, according to the company. Some labs across the country are reporting a short supply of swabs, which are needed for collecting patient samples to test for coronavirus infection, as well as reagents.​

"The test cartridge is a complete solution containing all the necessary reagents," according to Cepheid​. "This is different from some other test kits on the market which may require additional reagents such as extraction materials."

FDA has updated its COVID-19 diagnostic testing FAQs, which now lists the clinical labs that are offering testing, the states that have chosen to authorize labs to develop and perform tests, as well as commercial manufacturers that are distributing test kits. ​

Late week, FDA updated its policy impacting private and public labs and commercial manufacturers to increase U.S. capacity for coronavirus diagnostic testing. The updated policy enables states to take responsibility for authorizing ​tests developed and used by labs in their states. Nevada and Washington have joined New York in foregoing FDA's EUA process.

As of Monday morning, FDA had awarded EUA to 11 commercial tests. Among those awaiting FDA's go-ahead is BD, which announced submissions to the agency a week ago.

By Greg Slabodkin

Published March 23, 2020

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