FDA Panel Supports Roche HPV Assay To Replace Pap As Primary Cervical Cancer Screen
This article was originally published in The Gray Sheet
The Microbiology Devices Panel provided unanimous support Roche’s submission to upgrade labeling for it cobas HPV test as a first-line, primary screen for cervical cancer.
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The firm’s cobas human papillomavirus test is the first to gain approved labeling as a primary screen. It could be a market advantage for Roche, but the company now needs to work with clinical guideline developers to put the approved indication into routine practice.
The U.S. Preventive Services Task Force finds the evidence inconclusive for employing human papillomavirus testing as part of cervical cancer screening for women over 30, and it explicitly recommends against HPV testing in younger women.
Roche has been hiring additional sales reps and training its existing sales force in preparation for the U.S. launch of its cobas HPV test to identify women at high risk of developing cervical cancer.