Personal Injury Law

Ovarian Cancer Test OvaSure Being Marketed Without Necessary FDA Approval

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.

Full post as published by Legal Blog on October 10, 2008 (boomark / email).