WHEN THE FOOD AND DRUG ADMINISTRATION (FDA) sent Laboratory Corporation of America a letter in September declaring its marketing of the Ovasure test for ovarian cancer was a violation of the law, the news was widely reported.
Because Ovasure is a test that is being marketed as a home brew test, the fact that the FDA was taking some form of action caught the attention of the biotech industry and the genetic testing community. But with all the news reporting has come relatively little understanding of how LabCorp found itself in this position.
There are several elements to this story which are of interest to any laboratory offering a “home brew” lab test to clinicians. First, the FDA asserts that LabCorp is using materials not manufactured by LabCorp to perform the test. (The test was developed at Yale University and LabCorp has an agreement with Yale to market and perform the OvaSure test.) If that is the case, the FDA advises that LabCorp “must have an approved application for premarket approval (PMA).”
Oncologists Have Concerns
Second, there are a number of vocal critics that are unhappy at LabCorp’s decision to market this particular test. Within the ovarian cancer and women’s health communities, there are concerns that the patient population used to study the sensitivity and specificity of the OvaSure test had certain biases. These biases mean the test may not be accurate when used in the clinical settings targeted by LabCorp.
In particular, members of the Society of Gynecologic Oncologists have questioned the accuracy of the test. Some cancer specialists point out that the test could produce too many false positives, which would encourage women to unneccessarily have either their ovaries removed or exploratory surgery. If the test generates too many false positives, that would give woman a false sense of security.
Test Launched In June
LabCorp introduced the Ovasure test last June and it is priced at $220. The test measures six proteins in the blood and uses an algorithm to determine the probablity that the woman has cervical cancer.
The FDA letter was sent on September 29, 2008, and was posted on the FDA Web site in October. It was signed by Steven I. Guman, M.D., Office Director of the FDA’s Office of In Vitro Diagnostic Device Evaluation and Safety.
Lots of new legal and regulatory ground is likely to be broken as the matter proceeds to resolution. In recent years, the FDA has taken its first steps to place molecular diagnostics under some form of regulatory review and oversight. What may prove a vexing complication for LabCorp as it works to resolve this situation is the fact that elements of the women’s health community have lined up to oppose OvaSure as it is currently marketed by LabCorp.
As indicated in this intelligence briefing, there are many other elements to this LabCorp/FDA dispute that go unreported by the major news outlets. For that reason, stay tuned for the next installment in this unfolding story.