How Can A Company Market An Ovarian Cancer Screening Test If The FDA Says Women Shouldn’t Use It?

It is fitting that a Food and Drug Administration alert this week about tests marketed for ovarian cancer screening came out in September, drug which President Bill Clinton declared in 1998 to be National Ovarian Cancer Awareness Month.

The FDA’s “safety communication” warned that no currently available test is accurate and reliable for screening women who don’t have symptoms of ovarian cancer. That helps explain why, according to the American Cancer Society , ovarian cancer represents  only 3% of all malignancies in U.S. women but causes more deaths than any other cancer of the female reproductive tract. In the United States this year, 22,280 women will receive an ovarian cancer diagnosis and 14,240 women will die of it, the cancer society estimates.

The ovaries present a screening challenge because, situated in the pelvis, they’re not as accessible as, say, the breast or the cervix, both of which, of course, have cancer screening tests, and ovarian cancer symptoms usually don’t occur until the disease has metastasized. Even when symptoms do crop up–bloating, discomfort in the pelvis, quickly feeling full when eating, frequent urination–ovarian cancer typically isn’t the first thing that comes to women’s and doctor’s minds.

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