LabCorp, a major clinical laboratory company, offers a new blood test for early detection of ovarian cancer. The test was developed at Yale and is called OvaSure. Right now, symptoms such as pain and bloating are possible indicators of cancer, but those symptoms can also signal other conditions. Also, those symptoms may occur after the cancer has progressed. The American Cancer Society reports that this year over 21,000 women will be diagnosed with ovarian cancer, and 15,000 of them will likely die from the disease. Ninety percent of women whose cancer is detected at its earliest stages will reach the five year survival mark. But only 30 percent of women will live for five years if their cancer is detected in its latest stages.
These statistics demonstrate why it is so important to detect ovarian cancer early and why the availability of an early detection test raises hope among women and their doctors. However, there are also concerns raised by the OvaSure test. A statement issued by the Society of Gynocologic Oncologists reported that the test had not been validated enough for routine use. OvaSure was not reviewed by the FDA because generally the agency does not regulate tests developed and performed by a single laboratory, such as in this case. Last month, the FDA issued a letter to LabCorp, requesting more data about OvaSure. In addition, the FDA plans to regulate complex tests like OvaSure, but currently the policy is not finalized.