Roche Gets FDA Emergency Use Authorization for Monkeypox Virus Test
November 16 2022 - 1:54AM
Dow Jones News
By Pierre Bertrand
Roche Holding AG said Wednesday that its monkeypox virus test
has received emergency use authorization by the U.S. Food and Drug
Administration.
Cobas MPXV is a real-time PCR test which detects the presence of
monkeypox virus DNA from lesion swabs, the Swiss medical company
said.
The test targets two different regions of the virus' genome,
both of which are less prone to mutation, ensuring the test will
continue to identify cases of the virus even in the event of a
mutation in one of the test's target zones, Roche said.
The test received emergency use authorization by the U.S.
regulator after evaluating results from samples taken from
patients, rather than from a laboratory, Roche said.
Write to Pierre Bertrand at pierre.bertrand@wsj.com
(END) Dow Jones Newswires
November 16, 2022 01:39 ET (06:39 GMT)
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