Roche submits filing to FDA for cervical cancer screening indication

theflyonthewall.com

Roche announced it has submitted a Premarket Approval supplement to the FDA seeking the addition of a cervical cancer primary screening indication for the cobas HPV Test. Approval of the expanded indication would mean the cobas HPV Test could be used as the first-line test rather than Pap cytology as part of a cervical cancer screening strategy. The filing includes new three-year follow-up data from the ATHENA study, Roche's landmark U.S.-based registration trial, including more than 47,000 women screened for cervical disease with Pap and HPV tests.

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