LabCorp’s Ovarian Cancer Test Illegal: FDA

Boston, October 10: The Food and Drug Administration (FDA) issued a warning on Wednesday to the Laboratory Corporation of America that their blood-based ovarian cancerdefine test is illegal.

The FDA issued the following statement in their letter to LabCorp: “Because you do not have marketing clearance or approval from the FDA, marketing OvaSure is in violation of the law.”

LabCorp responded to the warning made by the FDA that its ovarian cancerdefine test, OvaSure, is not included in the scope of laboratory based-tests because it is under the category of a “home brew.” To be considered a home brew, the test must have been designed, developed and validated by a single company. OvaSure failed to fall under this category as it was found out that the said test was developed at Yale University and materials used were not produced by LabCorp.

LabCorp introduced their ovarian cancer test called OvaSure in June which was marketed for $220. This test is said to provide early detection of ovarian cancer by testing blood and measuring six proteins that can help identify the probability of ovarian cancer. However, experts argue that the cancer test has not been properly reviewed and proven accurate which may endanger women.

To test OvaSure, it was used on 224 blood samples of high and average-risk women and later on identified 95% of the cancers accurately. A false positive rate of 6% was also produced. This study appeared on the Journal of Clinical Cancer Research in February last year. The said results have not been confirmed by repeating the tests and may cause women to get ovarian surgery.

The Society of Gynecologic Oncologists made a statement last July that "additional research is needed to validate the test's effectiveness before offering it to women outside of the context of a research study."
The American Cancer Society estimated that more than 21,000 women will be diagnosed with ovarian cancer just for the present year.

There is a higher probability of survival if ovarian cancer is diagnosed at its early stage. At present, only 19% can be detected at that stage. The late detection of the cancer is one of the main reasons of the high mortality rate from this cancer.

Ovarian cancer is known as the “silent killer” because it does not produce symptoms specific to the disease. The cause of the disease is unknown but it has ranked 5th among the leading causes of cancer death in women.