Ovarian Cancer Test OvaSure Being Marketed Without Necessary FDA Approval By Levine & Slavit PLLC on October 10, 2008

The U.S. Food and Drug Administration warned clinical test giant Laboratory Corp. of America Holdings that it was marketing OvaSure, an ovarian cancer test, in violation of the law in that it did not have marketing clearance or approval from the FDA. OvaSure measures six proteins in blood samples and calculates the chances that the woman has ovarian cancer. LabCorp made the $220 test available in June, under a provision that exempts tests developed and offered by a single lab from the usual FDA review. Thus OvaSure did not go through an FDA review. But in a letter dated September 29 and released October 7, 2008, the FDA determined that because the test was developed at Yale School of Medicine but that parts of it were manufactured elsewhere, it must meet the agency's usual premarketing approval requirements, which could take up to a year. OvaSure does not diagnose cancer - it attempts to predict the likelihood of someone having the disease - which caused many experts to believe that it would be prematurely cause women to undergo unnecessary surgical removal of their ovaries based upon OvaSure results. The Society for Gynecologic Oncologists also issued a statement last July saying additional research was required before OvaSure was offered to women outside of research settings. Discovering a way to diagnose ovarian cancer early has been a priority of researchers inasmuch as it usually is not found until it has already spread outside the ovaries, when it is very often fatal. More than 21,000 new cases of ovarian cancer are diagnosed annually in the U.S.; more than 15,000 women die of it each year. When ovarian cancer is caught early, the five-year survival rate is over 90%, according to the American Cancer Society. But only about 20% of cases are caught that early. When it is discovered later, the five-year survival rate is less than 30%. More than 90 per cent of women with ovarian cancer will live at least five years if it is detected at its earliest stage, when it is still confined to the ovaries, says the American Cancer Society. The few early symptoms of ovarian cancer are pelvic or abdominal pain, digestive upsets, bloating or swelling in the abdomen, fatigue, changes in bowel habits and unexplained weight gain or loss. Several other academic medical centers are testing their own possible blood and genetic markers for ovarian cancer. Researchers at Yale are continuing tests on OvaSure and expect to have more data later this year. Tests for the gene mutations known as BRAC1 and BRAC2 can tell women whether they are at higher risk of breast or ovarian cancer, or both. But having the gene mutations isn't definitive either. Women with a BRCA mutation have between a 15% and 45% chance of getting ovarian cancer at some point in their lives, according to Dr. Sutphen. But only one out of every eight cases of ovarian cancer involves one of those mutations, she said, so there are clearly many other factors at work.

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