OVA1 test is FDA cleared for women who meet the following criteria: (i) over age 18, (ii) ovarian mass present for which surgery is planned, and (iii) not yet referred to an oncologist. It is an aid to assess the likelihood that ovarian cancer is present when a physician is not sure. The test should not be used without a prior independent prior clinical/radiological evaluation and is not intended to be a screening test or to determine whether a patient should proceed to surgery. Incorrect use of the OVA1 Test carries the risk of unnecessary testing, surgery, and/or delayed diagnosis. The test has certain advantages. Two recent articles in Obstetrics and Gynecology suggest that it is a more sensitive test than Ca-125. However, sensitivity comes at the price of more false positive tests. The OVA1 test incorrectly identified non-cancerous masses about twice as often as CA 125 or clinical assessment. A higher false positive rate may increase patient distress and the number of surgeries that end up being performed.
Of more importance is the decreased number of false negatives or undetected cancers when OVA1 is added to a physician’s assessment This number is reduced from 28% to 8% in non-gynecologic oncologist assessment and from 21% to 1% in gynecologic oncologist assessment. This translates into potentially more cancers being referred to a gynecologic oncologist for initial surgery. The investigators go on to say, “Hopefully, earlier referral of patients with ovarian cancer will improve survival and reduce the number of required re-operation.” However, guidelines have not fully incorporated this test into their follow-up strategy or their assessment of recommendations on how to assess an ovarian mass. NCCN does not recommend or discuss this test.
ACOG/SGO Committee Opinion: Number 477 (March 2011) recommends that a woman with a suspicious or persistent complex ovarian mass requires surgical evaluation by a physician trained to appropriately stage and reduce the bulk of ovarian cancer. When referring to OVA1, the Committee states that OVA1 “appears to improve the predictability of ovarian cancer in women with pelvic masses. “A letter dated September 2009 issued by the Society of Gynecologic Oncologists recognized the importance of OVA1 stating that it “…may help healthcare providers better detect when referral to a gynecologic oncologist is indicated.”
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