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FDA Panel Supports Roche HPV Assay To Replace Pap As Primary Cervical Cancer Screen

This article was originally published in The Gray Sheet

Executive Summary

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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Roche’s HPV Test Approved As First-Line Cervical Cancer Screen

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.

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