A Closer Look at HPV

HPV affects approximately 20 million Americans, with 6 million new infections
annually. This common STI has about 130 strains, with some causing warts and others leading
to cancer. HPV can be prevented through regular screenings, safe sex practices, and
vaccination.

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Coalition Letter to FDA Commissioner Hamburg About Approving Cobas HPV Test Alone (Without Pap Smear) and FDA Response

April 11, 2014. We are writing as members of the Patient, Consumer, and Public Health Coalition and other interested experts to express our grave concerns about the March 12, 2014 FDA meeting of the Microbiology Medical Devices Panel of the Medical Devices Advisory Committee. Under consideration was the premarket approval of a new indication for the Cobas HPV test, as a first-line primary screening tool for cervical cancer in women aged 25 and older.

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