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FDA panel backs expanded label for Roche HPV test

March 13, 2014 1:02 AM UTC

FDA's Microbiology Devices Advisory Committee voted 13-0 on Wednesday that the benefits of expanding the label of the cobas HPV test from Roche (SIX:ROG; OTCQX:RHHBY) to include primary screening for cervical cancer outweigh the risks. The committee also voted unanimously that Roche provided "reasonable assurance" that the test is safe and effective for the expanded indication, which the pharma said would allow for first-line use of the test in place of pap cytology as part of cervical cancer screening. Roche declined to comment on when it expects a decision from FDA. ...