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FDA Issues Emergency Use Authorization for Roche's Coronavirus Test

By Brian Orelli, PhD - Mar 13, 2020 at 2:23PM

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The test can produce results in under four hours.

The Food and Drug Administration issued an Emergency Use Authorization for Roche's (RHHBY 1.11%) cobas SARS-CoV-2 test, which detects the novel coronavirus that causes COVID-19. Shares of Roche were up 7.4% at 1:25 p.m. EDT on Friday on the news.

The test runs on Roche's cobas 6800 and cobas 8800 Systems, which are installed in diagnostic laboratories in the U.S. and across the world. The test takes three and a half hours to run, and the machines can run multiple tests at the same time, allowing for a total of 1,440 results in 24 hours for the cobas 6800 System and 4,128 results for the cobas 8800 System.

Roche plans to make millions of tests per month available.

Gloved hand holding a vial of blood marked as positive for the coronavirus

Image source: Getty Images.

The FDA's Emergency Use Authorization is granted with less data than would be required for a full approval, but it only remains in effect while the emergency is ongoing. Roche will need to apply for clearance or approval if it wants to continue selling the test once things settle down.

Roche's test is the first commercially available test to gain this authorization. A test developed by the Centers for Disease Control and Prevention was granted Emergency Use Authorization last month, as was one from New York State Department of Public Health. OPKO Health (OPK -1.36%) is using New York's test through its BioReference Laboratories to set up a drive-through testing facility in New Rochelle, the epicenter for the New York State outbreak.

Earlier this month, LabCorp (LH 1.07%) and Quest Diagnostics (DGX 0.49%) began offering COVID-19 tests. LabCorp said it was making test results available in three days.

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Stocks Mentioned

Roche Holding AG Stock Quote
Roche Holding AG
$41.82 (1.11%) $0.46
Quest Diagnostics Incorporated Stock Quote
Quest Diagnostics Incorporated
$137.13 (0.49%) $0.67
OPKO Health, Inc. Stock Quote
OPKO Health, Inc.
$2.54 (-1.36%) $0.04
Laboratory Corporation of America Holdings Stock Quote
Laboratory Corporation of America Holdings
$238.48 (1.07%) $2.52

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