FDA warning leads to halt in ovarian cancer test sales
by Anna
Web Correspondent
Planned Parenthood Minnesota, North Dakota, South Dakota Action Fund
Alas, things are never that simple. LabCorp, the clinical laboratory company that produced and marketed the test, received an FDA warning letter on September 29 stating that the company was illegally selling the test without FDA approval. Typically, when a test is developed by an individual private laboratory, FDA verification is not required. In this case, however, LabCorp developed OvaSure at Yale University. According to the FDA, collaboration with a research university means that the product is not exempt and must obtain approval before going on the market. Last Thursday, October 24, LabCorp announced that it would halt sales of the test in accordance with FDA policies.
Legal intricacies abound—and to be honest, I can’t claim to fully understand what needs FDA approval and what does not, or why. One medical item of interest within this controversy, though, is the claim by groups like the Society of Gynecologic Oncologists that OvaSure is not necessarily accurate because it can produce false positive results. In initial testing by LabCorp the test had a false positive rate of about 6 percent, identifying 95 percent of cancers correctly, but the SGO says the false positive rate may be even higher. These false positives, even if they are infrequent, could lead to unnecessary surgeries, opening up a whole new line of inquiry—is it worth the risk?
Ovarian cancer is often called the “silent killer” because it often shows no symptoms in its early stages. Once it becomes more advanced, chances of surviving the disease are farm slimmer. 80 percent of cases go unnoticed until this early stage, in which the cancer is often curable, has passed. About 21,000 cases are diagnosed every year, and while the five-year survival rate is as high as 92 percent when the cancer is caught before spreading, the rate is only 30 percent when the cancer is already advanced. The key issue here is obviously catching ovarian cancer early on, and tests like OvaSure, if approved by the FDA, could play a crucial role in providing this early detection.
Not that I’m advocating a quick and rash decision to put OvaSure back on the market—on the contrary, I think LabCorps needs to get the politics all squared away by trying to obtain FDA approval. Of course, if the SGO is correct and the false positive rate comes out too high, the company has some substantial kinks to work out before the test can become available. If this is not the case and the test is deemed reliable, let’s hope it finds its way back into the hands of doctors and women as quickly as possible.
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