Roche Gets FDA Approval for Malaria Screen Test
Provided by
Dow Jones
By Pierre Bertrand
Roche Holding said it received regulatory approval in the U.S. for its molecular test that screens for the presence of malaria in donated blood.
The U.S. Food and Drug Administration approved the company's Cobas Malaria test, Roche said in a statement Tuesday, adding that it was the first such approved test to screen U.S. blood donors for malaria by the federal body.
The tests will be available in the U.S. at the end of the second quarter this year. Approval in European Union countries is anticipated later this year, Roche said.
Write to Pierre Bertrand at pierre.bertrand@wsj.com
(END) Dow Jones Newswires
March 26, 2024 13:19 ET (17:19 GMT)
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