OCNA Encouraged by Release of OvaSure test for Ovarian Cancer

June 24, 2008

Today, The Laboratory Corporation of America (LabCorp) announced that OvaSure, a test to detect ovarian cancer, would be available through its laboratories immediately. The Ovarian Cancer National Alliance is heartened by advances in early detection of ovarian cancer, and continues to urge women to remain vigilant about the signs and symptoms of ovarian cancer.

This year, more than 21,000 women will be diagnosed with ovarian cancer, and more than 15,000 women will die of the disease. Fewer than 20 percent of women are diagnosed in Stage I, when the chance of survival is greatest. A scientifically based early detection test, combined with awareness of the signs and symptoms of ovarian cancer, will help women get diagnosed early, and live longer, fuller lives.

OvaSure is a blood test performed in regulated laboratories. As a laboratory developed test, it is not FDA approved but does not require FDA approval for sale. “We look forward to the publication of Phase III trial data from the study later this year validating the test. This may, indeed, be a massive breakthrough in the detection of ovarian cancer,” said Dr. Karen Orloff Kaplan, Sc.D., Executive Director.

According to LabCorp, the test is available as of June 24, and may be covered by insurance companies. OvaSure is meant to be offered for women with a high risk of developing ovarian cancer, including those at risk for a recurrence. The test will sell for approximately $225, and results will be available within four business days. The test is 99.4 percent accurate for positives (sensitivity) and 95.3 percent accurate for negatives (specificity).


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The Ovarian Cancer National Alliance supports evidence based medicine and works with Congress to fund research and awareness programs related to ovarian cancer. The Ovarian Cancer National Alliance strongly encourages women to participate in clinical trials through its partnership with EmergingMed and its Clinical Trials Forum at its Annual Conference.