FDA Says LabCorp Violating Law
Today the FDA told LabCorp, Burlington, NC, that it is violating the law by marketing its OvaSure test without regulatory approval.
The FDA said in a letter that if LabCorp did not stop selling the ovarian cancer test, it could face seizure, injunction or monetary fines. Click here for more information.
The OvaSure test had previously been under fire. In August, the Society of Gynecological Oncologists told the New York Times that the organization believed the test hadn't been validated enough for routine use. The FDA said the test had also not been proved to work.
OvaSure measures the six proteins in a woman's blood, and then calculates the probability the woman has ovarian cancer.