FDA advisory committee recommends Roche's HPV test for primary screening of cervical cancer.

A new Human Papillomavirus (HPV) test developed by Roche was unanimously recommended by an FDA Advisory Committee as a first-line primary screening tool in women 25 years and older to assess their risk of cervical cancer based on the presence of clinically relevant oncogenic HPV DNA. The advantage of sub-typing highest-risk oncogenic HPV16 was clearly demonstrated by identifying cervical precancer in nearly 1 out of 7 women with normal Pap cytology.

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