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FDA Slams LabCorp for Selling Unapproved Ovarian Cancer Test

Posted on October 08, 2008

The FDA has warned clinical-test giant LabCorp that it has been marketing an ovarian cancer test without approval, vindicating skeptics of the assay who worried it wasn t ready for prime time. OvaSure, developed by researchers at Yale, measures six proteins in blood samples and calculates the chances that a woman has ovarian cancer. LabCorp made the $220 test available in June, without prior FDA review, by taking advantage of a technicality. The regulator doesn t require a premarket review for tests developed and performed by a single lab. But in a letter dated Sept. 29 and released today...

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cancer , proteins