FDA: Ovarian Cancer Test Not Approved

A blood test for ovarian cancer is being sold illegally, U.S. drug regulators say. The OvaSure test is made by the Laboratory Corporation of America. In a September 29 letter, the U.S. Food and Drug Administration (FDA) has warned the company that the test needs FDA approval. Not all medical tests need this approval. But the FDA said OvaSure does need it. OvaSure was first sold in June. It looks for six proteins in the blood. Based on the protein levels, the woman gets an estimate of her chance of having ovarian cancer. But some experts say the test has not been studied enough to prove it works. The New York Times wrote about the warning letter October 9.