Ovarian Cancer: What is OVA1® Test?

• While ovarian cancer may not be as common as some other cancers, there are approximately 22,280 new cases diagnosed in the United States each year. Because it is often detected when it is more advanced, over 15,000 women in the U.S. die from the disease each year. Despite clinical data supporting the referral of all women with suspected ovarian cancer to a gynecologic oncologist, less than 50 percent of ovarian cancer patients actually have their initial surgery performed by a gynecologic oncologist. 

  It has been extensively documented that initial surgery by a gynecologic oncologist rather than a gynecologist, is associated with a higher likelihood of complete staging, optimal resection of tumor, and better overall survival. One major obstacle to appropriately referring patients with an ovarian mass to a specialist is the difficulty identifying who is most likely to have ovarian cancer. There is no screening test for ovarian cancer, unlike the Pap test for cervical cancer or a mammogram for breast cancer. Particularly challenging groups of patients are those with early-stage ovarian cancer (of whom 50 percent will receive normal CA-125 test results) and pre-menopausal women, where the occurrence of cancer is relatively low. CA-125 is a protein that is a tumor marker, or a substance that is detected in greater concentration in cancerous cells than in healthy cells. It is more likely to be identified in ovarian cancer cells.

  

  So how can we help diagnose ovarian cancer earlier when it is more treatable? The OVA1 ® test is a multiple biomarker blood test that was approved by the U.S.Food and Drug Administration (FDA) in 2009. It tests for CA125, transferring, prealbumin, apolipoprotein A1 and beta-2-microglobulin. The individual biomarker test results are then transformed by computer software to generate an ovarian malignancy risk score. The risk score cut-off is different based on your menopausal state. This blood test is not a screening test that can be used to test asymptomatic women without ovarian masses.  This test was developed to help the general practitioners during preoperative workup of ovarian mass. OVA1 helps to identify those women who need referrals to a gynecologic oncologist prior to their surgery. An abnormal OVA1 test does not necessarily mean you have cancer. It simply means that you need a specialist to evaluate you prior to undergoing surgery.

  A recent prospective multi-institutional clinical trial published in the November 2012 issue of Gynecologic Oncology studied almost 500 women scheduled to undergo surgery for an ovarian mass. The researchers looked at OVA1, CA-125, and clinical assessment made by the physician and correlated with final surgical pathology. OVA1 was more sensitive in detecting ovarian cancer than clinical impression and CA125. When OVA1 and clinical impression was used together, sensitivity of detecting ovarian cancer was 96 percent.

  What does this mean? If a doctor suspected an abnormal ovarian mass suspicious for cancer and the OVA1 test was abnormal, there is a high chance that the woman may have ovarian cancer. These women need referrals to see a gynecologic oncologist. A low-risk OVA1 test result correctly predicted the absence of malignancy by 98 percent. The authors concluded that the OVA1 test is a useful blood test to check prior to surgery performed by general gynecologist. The limitation of this study is that all women were undergoing planned surgery for ovarian mass. In these women, the prevalence of pelvic malignancy would be expected to be higher than those women whom surgery is not planned. We do not know how useful this blood test is in women where surgery is not planned.

  Stay tuned for additional information as we learn more about the OVA1 test results.