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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.

Roche Molecular Diagnostics’ cobas human papillomavirus DNA gained FDA approval April 24 as a first-line primary screening tool for cervical cancer in women 25 and older, giving the firm a potential leg up in the competitive HPV assay space.

The cobas HPV assay has been approved for use in conjunction with routine a Pap smear cell cytology test since...

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