Ovarian Cancer Screen? Not So Fast

October 13th, 2008 | Sources: Wall Street Journal

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Few cases of ovarian cancer are detected at an early stage, and late-stage disease responds poorly to treatment. The situation begs for an inexpensive, noninvasive screening test.

Last February, Yale scientists published the results of a blood test for ovarian cancer. Assaying for six disease-related proteins, the test correctly identified ovarian cancer in 95% of samples and it had a low false positive rate, 0.6%.

These results encouraged many. The Yale group and others launched follow-up studies. Others raised concerns that routine use of the test would trigger a flood of expensive follow-up testing and risky surgeries including the removal of non-cancerous ovaries.

Ovarian cancer screening was, alas, still a work-in-progress.

LabCorp had another idea. It began marketing Yale’s blood test in June for $220, believing it could side-step routine FDA review on a technicality that exempts tests developed at a single laboratory.

“Not so fast,” was the FDA’s response in a recent letter to the Burlington, North Carolina firm. Yale researchers developed the test it is true, but parts for the test were manufactured elsewhere. The test will have to go through a routine approval process which might take a year or more.

So for now we’re left advising women to be aware of symptoms which might be caused by ovarian cancer: pain or swelling in the pelvic or abdominal area, changes in bowel habits, weight loss and fatigue.  Perhaps though, we have reason for hope.


 

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