In 2010, approximately 21,880 women will be diagnosed with ovarian cancer in the United States and 13,850 women will succumb to this disease. Although 90% of ovarian cancers can be treated at stage I with the currently existing surgical and chemotherapeutic regimens, only 25% of ovarian cancers are detected at this treatable stage due to the non-specific ‘silent’ symptoms and the lack of effective screening procedures. Given the low prevalence of ovarian cancer (1 in 2500 post menopausal women), an extremely high specificity (99.6%) and sensitivity (> 75%) are required to achieve a minimum PPV of 10% (10 laparotomies per case of ovarian cancer detected). No single screening test exists currently for recommended use in the general population, underscoring the need for novel early detection and screening methods.
For suspected pelvic masses, diagnosis of ovarian cancer is realized by pelvic examination, transvaginal sonography (TVS) and serum CA125 leading to exploratory or diagnostic laparoscopy. TVS provides a precise image of the ovary and while PPVs in the most promising studies have been reported to be close to 10%, prohibitively high costs for implementation have precluded its utility as a first line screen. Serum CA125 has been extensively utilized in advanced stage disease management and has been FDA approved for recurrent disease detection and monitoring chemotherapy response. However, CA125 is elevated in only 50-60% of early stage cancers with false positives for a variety of non-malignant gynecological and physiological conditions.