FDA advisory committee unanimously recommends Roche Holding AG's HPV Test as primary screening tool for detection of women at high risk for cervical cancer


Wednesday, 12 Mar 2014 06:47pm EDT 

Roche Holding AG:Says that U.S. Food and Drug Administration (FDA) microbiology devices panel of medical devices advisory committee recommended unanimously that the benefits of cobas HPV (Human Papillomavirus) test as first-line primary screening tool.In women 25 years and older to assess their risk of cervical cancer based on presence of clinically relevant high-risk HPV DNA outweigh risks.Panel also voted unanimously that cobas HPV Test is safe and effective for proposed indication for use.If approved, cobas HPV Test would become first and only HPV test indicated as first-line primary screen of cervical cancer in the United States. 

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