OVA1 test is FDA cleared for women who meet the following criteria: (i) over age 18, (ii) ovarian adnexal mass present for which surgery is planned, and (iii) not yet referred to an oncologist. It is an aid to further assess the likelihood that malignancy is present when the physician’s independent clinical and radiological evaluation does not indicate malignancy. The test should not be used without an independent 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.Two recent articles in Obstetrics and Gynecology suggest that this is a more sensitive test than Ca-125. 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 specialists unnecessarily perform. . OVA1 false positive rate is in line with real-world referral patterns.
Of more importance is the decreased number of false negatives or undetected cancers when OVA1 is added to a physician’s assessment, which 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 followup strategy or their assessment of an adnexal mass recommendations. 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 adnexal mass requires surgical evaluation by a physician trained to appropriately stage and debulk 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.” – Download SGO_Statement
Read the Layperson version here.