A new test, called OVA1 (Vermillion, Inc.), can help detect ovarian cancer in a pelvic mass. OVA1 drug identifies some women who will benefit from referral to a gynecological oncologist for surgery despite negative results from other tests for ovarian cancer. If other test results suggest cancer, referral to an oncologist is appropriate even with a negative OVA1 result.
Generic OVA1 should be used as an adjunctive test to complement, not replace, other diagnostic and clinical procedures. A blood sample is obtained to test for levels of five proteins that change in the presence of ovarian cancer.
The test is intended only for women 18 years of age and older who are already candidates for surgery because of a pelvic mass. OVA1 is not indicated for ovarian cancer screening or for arriving at a definitive diagnosis of ovarian cancer.
Source: FDA, September 11, 2009