Clinical trial data and a Food and Drug Administration panel’s full-throated endorsement stand to reshape cervical cancer screening practice recommendations in the U.S.
The FDA’s Microbiology Devices Advisory Committee in March voted 13-0 in favor of a new indication for Roche’s Cobas human papillomavirus test that would allow the assay to be used as a primary screen for cervical cancer in women 25 and older. At this article’s deadline, the FDA had not yet acted on the panel’s advice but the agency usually heeds its advisory committees’ recommendations.
My latest in CAP TODAY’s Put it on the Board section. Read the whole shebang.