The U.S. Food and Drug Administration has approved the OVA1™ test for women who require surgery for an ovarian mass. The OVA1 test assesses the likelihood that ovarian cancer is present and requires surgery by a gynecologic oncologist.

Each year an estimated 300,000 surgeries are performed in the United States to evaluate ovarian masses. For women with ovarian cancer, outcomes tend to be best when surgery is performed by a gynecologic oncologist. Before surgery is performed, however, it can be difficult to predict which ovarian masses are cancerous.

If standard clinical and radiological assessments suggest ovarian cancer, referral to a gynecologic oncologist is appropriate. If these tests are negative, however, additional testing with OVA1 may be useful in guiding surgeon selection. The OVA1 Test is a qualitative serum test that combines the results of five immunoassays into a single numerical score. It is indicated for women who meet the following criteria: over age 18, ovarian adnexal mass present for which surgery is planned, and not yet referred to an oncologist. The test utilizes five well-established biomarkers—Transthyretin (TT or prealbumin), Apolipoprotein A-1 (Apo A-1), Beta2-Microglobulin (Beta2M), Transferrin (Tfr), and Cancer Antigen 125 (CA 125 II)—and a proprietary algorithm to determine the likelihood of malignancy in women with pelvic mass for whom surgery is planned. The OVA1 test has been shown to identify women who would benefit from surgery by a gynecologic oncologist but who were not identified as such by standard pre-surgical evaluation.

The OVA1 test has been cleared by the U.S. Food and Drug Administration. It is intended only for women who are 18 years of age or older and who are already selected for surgery because of an ovarian mass. The test is not intended to be used as a screening or diagnostic test. The test can supplement (but not replace) other standard clinical and radiological tests.

Comments: This test is not approved as a screening test for women who do not have a suspicious mass.

References:

FDA news release. FDA clears a test for ovarian cancer. Available at: http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/2009/ucm182057.htm Accessed March 10, 2010.

Quest Diagnostics press release. OVA1 Blood Test Now Available to Aid Pre-surgical Evaluation of Women for Ovarian Cancer. Available at: http://questdiagnostics.mediaroom.com/index.php?s=43&item=397 Accessed March 10, 2010.