FDA Says New Ovarian Cancer Test is Illegal to Sell
The FDA has halted sales of a blood test called Ova Sure that measures six proteins it says can diagnose ovarian cancer in women. Laboratory Corp of America side stepped the usual FDA review process and was notified that there is not enough research data to market the test. The FDA says Ova Sure, developed by researchers at Yale School of Medicine, is illegal to sell at this time.
Ova Sure was being marketed without the usual FDA review by using a loophole that said if a test was developed and offered by a single lab it was exempt from oversight. But the FDA has determined that it must meet the agency’s usual premarketing approval requirements, which could take up to a year.
In its warning letter to LabCorp, the FDA states, “Because you do not have marketing clearance or approval from the FDA, marketing OvaSure is in violation of the law.” The company stated selling the blood test in June, saying it could detect early-stage ovarian cancer in high-risk women.
Ova Sure was tested on 224 blood samples and identified 95% of cancers correctly. There was a false positive rate of 6%. Those results have not been validated by repeat tests and many experts fear it could yield too many false positives and false negatives and influence women to undergo surgery or even ovary removal. The Society of Gynecologic Oncologists maintains that the test is ineffective and too imprecise to detect ovarian cancer.
Ovarian Cancer strikes fear into most women because it has few warning signs and 80% of cases are not caught early when it is curable. Known as the “silent killer”, more than 21,000 cases of ovarian cancer are diagnosed annually in the United States. Women and their physicians have been looking for a screening test to find early ovarian cancer for decades. Unlike mammograms or pap tests, there has been no test available that screens for or detects early ovarian cancer.
The cause of ovarian cancer is unknown but there is increased risk in older women and in those who have a first or second-degree relative with the disease. Specific genes (BRCA1 and BRCA2) and genes for hereditary nonpolyposis colorectal cancer have been identified as being a risk for ovarian cancer.