The U.S. Food and Drug Administration (FDA) has approved a qualitative serum test termed OVA1, which can identify ovarian cancer in a pelvic mass prior to exploratory surgery. The test has been developed by the molecular diagnostics company, Vermillion Inc., in collaboration with scientists at the Johns Hopkins University.
OVA1 is meant for women aged 18 years or older who have been scheduled for biopsy or exploratory surgical treatment for their pelvic mass. It identifies those who require oncological treatment for their pelvic mass even when negative results have been obtained from clinical and radiographic tests for ovarian cancer. However, a negative OVA1 test in a woman with suspected malignancy on radiological and clinical evaluation, should not prevent the gynecologist from referring the patient to an oncologist. The test should not be used without a clinical and radiological assessment. It is not intended to be a screening or a definitive diagnostic tool and should be used as an adjunct to other diagnostic procedures.
The test is based on the estimation of the levels of five proteins (transthyretin, apolipoprotein A1, transferrin, beta-2 microglobuliin, and cancer antigen 125) in blood, which is then combined into a single score, ranging from 0 to 10, using a unique algorithm. The score is then used to predict whether the pelvic mass is benign or malignant. The result interpretation requires information regarding whether the woman is pre- or post-menopausal.
The American Cancer Society (ACS) estimates that approximately 15,000 deaths are attributable to ovarian cancer in the country, annually. The malignancy is often diagnosed in the later stages when the prognosis is poor. The 5-year survival rate for stage 1 is around 90%, whereas for stage III or IV, which is most often the stage at which the tumor is diagnosed, is less than 30%. Vague symptoms of the disease, such as abdominal discomfort, gas, bloating, nausea and urinary urgency, which may not manifest until the disease is advanced makes early detection a challenge. The organs’ inaccessible location further adds to the difficulty in diagnosis. At present, the best diagnostic tools available are transvaginal ultrasonography and serum biomarker testing.
The American College of Obstetricians and Gynecologists (ACOG) estimates that 5 to 10% of American women will undergo a surgical procedure for a suspected ovarian tumor during their lifetime. Approximately one-fifth of the pelvic masses are malignant; the proportion being even greater in menopausal women. The adoption of OVA1 in regular clinical practice could significantly improve the survival rates, as the test helps in identifying additional patients requiring early referral to a gynecological oncologist for laparotomy and surgical staging of the cancer.
About Vermillion: Based in Fremont, California, Vermillion is involved in the development of novel diagnostic tests which aid in early diagnosis and successful treatment. The company, in collaboration with the Ohio State University Research Foundation, has successfully developed an assay for thrombotic thrombocytopenic purpura recently, and is currently working on diagnostic tools for peripheral artery disease and ovarian cancer.
References
1. FDA clears a test for ovarian cancer. Press Release. FDA. Last accessed September 17, 2009.
2. Karst AM, Drapkin R. Ovarian cancer pathogenesis: a model in evolution. J Oncol. 2010;2010:932371.
3. Ueland FR, Zhang Z, Crutcher G, Fung ET. A biomarker panel for distinguishing between malignant and benign ovarian tumors. San Antonio, TX: Vermillion; Last accessed September 22, 2009.
