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Ovarian Cancer Test Illegal: FDA2008.10.15

A blood test to detect ovarian cancer is being marketed illegally by the Laboratory Corporation of America, the U.S. Food and Drug Administration said in a warning letter posted on its Web site Wednesday.
The OvaSure test, introduced in June, promises to detect ovarian cancer at an early stage, when it's still treatable. However, experts say the test hasn't been proved accurate and might cause women to undergo unnecessary surgeries to remove their ovaries, The New York Times reported.
In a previous letter to LabCorp, the FDA said the test "may harm public health." The new warning letter, sent to LabCorp on Sept. 29, says the OvaSure test requires FDA approval before it can be marketed.
LabCorp spokesman Eric Lindblom told the Times that the company is currently in discussions with the FDA, but wouldn't say whether the test would be removed from the market.


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