The science-services provider Thermo Fisher said it received emergency-use authorization from the Food and Drug Administration to market its diagnostic test for the coronavirus.
The test “can be used immediately by [Clinical Laboratory Improvement Amendment] high-complexity laboratories in the U.S. to detect nucleic acid from SARS-CoV-2, the virus that causes Covid-19, and not for any other viruses or pathogens,” the company said in a statement.
“The authorized test uses Applied Biosystems TaqPath Assay technology and is designed to provide patient results within four hours of a sample being received by a lab. The estimated time-to-result also includes time for sample preparation and instrument analysis.”
Thermo Fisher said it had 1.5 million tests available to ship and expects to quickly ramp up to two million tests a week. The company expects to increase production up to five million tests a week during April.
Thermo Fisher is the second company and the fourth entity to receive FDA emergency clearance for a coronavirus diagnostic test.
A test developed by diagnostics giant Roche Holding (RHHBY) received clearance Friday. The other two are tests from the Centers for Disease Control and Prevention and from the New York State Department of Health.
Until two weeks ago only the CDC had permission to conduct tests. And some of those turned out to be inaccurate. The CDC says it has fixed that.
On Monday the stock market was halted at the open as a flood of selling triggered a circuit breaker. At last check Thermo Fisher shares traded at $289.12, down 3.7%. In 2020 through Friday the shares were off 7.6%.