FDA board recommends new HPV testing, machine made by local company

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INDIANAPOLIS – A U.S. Food and Drug Administration advisory board has new recommendations for how women are screened for the Human Papillomavirus.

Last week, the committee unanimously recommended Indianapolis-based Roche Diagnostics HPV test replace Pap smears as the primary method of screening women for cervical cancer.

“The retrieving of the specimen still requires an examination. Everything as far as collecting the specimen is the same for a woman. What we’re doing is proposing a different type of testing,” said Roche Diagnostics Chief Medical Officer Dr. Alan Wright.

HPV causes more than 90 percent of cervical cancers. Every year 12,000 women are diagnosed in the U.S. with cervical cancer. However, not all doctors agree with the cobas HPV machine replacing Pap smears.

“The HPV is not the only risk you have for cervical cancer. It is the most important one. But there are other things. So the woman’s cervix needs to be examined and I say some exam of the pelvis needs to be done, said Indianapolis Ob/Gyn Dr. Mary Bush.

While this is only a recommendation from the advisory board the FDA does not have to agree, but it usually does.

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