The Food and Drug Administration issued an Emergency Use Authorization for Roche's (OTC: RHHBY) 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.
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 (NASDAQ: OPK) 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 (NYSE: LH) and Quest Diagnostics (NYSE: DGX) began offering COVID-19 tests. LabCorp said it was making test results available in three days.
10 stocks we like better than Roche
When investing geniuses David and Tom Gardner have a stock tip, it can pay to listen. After all, the newsletter they have run for over a decade, Motley Fool Stock Advisor, has tripled the market.*
David and Tom just revealed what they believe are the ten best stocks for investors to buy right now... and Roche wasn't one of them! That's right -- they think these 10 stocks are even better buys.
*Stock Advisor returns as of December 1, 2019
Brian Orelli and The Motley Fool have no position in any of the stocks mentioned. The Motley Fool has a disclosure policy.
The views and opinions expressed herein are the views and opinions of the author and do not necessarily reflect those of Nasdaq, Inc.
