Resources for Food and Drug Administration (FDA)

F.D.A. Says Cancer Test Failed to Get Its Approval

www.nytimes.com

The Food and Drug Administration has told the Laboratory Corporation of America that it is illegally marketing a blood test to detect ovarian cancer, according to a warning letter posted Wednesday on the F.D.A.’s Web site. The test, introduced in June, has raised hopes among women and their doctors because it promises to detect ovarian cancer at an early stage, when it is still treatable. But some outside experts, including the Society of Gynecologic Oncologists, have said the test had not been proved accurate and might cause women to have unnecessary surgeries to remove their ovaries. The F.D.A. itself, in a previous letter to LabCorp, said the test “may harm the public health.”

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