Only an estimated one-third of women who have a malignant ovarian tumor are operated on by gynecologic oncologist for the initial removal of the cancer.¹ However, leading medical associations, including the National Comprehensive Cancer Network and the Society of Gynecologic Oncologists, recommend that women with an ovarian adnexal mass suspicious for cancer be referred to a gynecologic oncologist for surgery.

OVA1 provides new, objective information to help physicians refer women to the most appropriate surgeon — potentially helping to promote better treatment outcomes.

How does a physician typically evaluate a patient with an ovarian mass?

The initial evaluation of an ovarian mass generally includes a patient history, physical examination and imaging, typically ultrasound. The physician may base their examination protocol on training, experience or the guidelines published by the American College of Obstetricians and Gynecologists (ACOG) and the Society of Gynecologic Oncologists (SGO).  The findings during a pelvic examination are often ambiguous, but may assist the physician in determining the location, size and mobility of the tumor. Physical examination alone is not a reliable predictor of whether an ovarian tumor is benign or malignant.

Pelvic ultrasound can provide valuable information about an ovarian tumor, specifically volume measurement and tumor morphology (wall thickness, papillary projections, solid areas, and ascites); however it cannot be used to definitively diagnose malignancy.

What type of physician would use OVA1?

An obstetrician and/or gynecologist (ObGyn) is most likely to find and evaluate an ovarian  mass.  However, medical guidelines recommend women with ovarian cancer be refered to a gynecologic oncologist for their treatment.

How is OVA1 different than CA 125?

OVA1 is the only blood test cleared by the FDA for pre-surgical evaluation of a woman with an ovarian mass. CA 125 is intended for use as an aid in monitoring patients previously treated for ovarian cancer. CA125 is one of the five biomarkers included in the OVA1 score.

How accurate is OVA1?

A physician's typical pre-surgical assessment for an ovarian  mass may include using a combination of physical examination, clinical evaluation, and imaging such as pelvic ultrasound and/or CT scan. A prospective, double-blind clinical trial evaluated the sensitivity and specificity of pre-surgical assessments that included results of OVA1 compared to those that did not. The evaluations were performed by non-gynecological oncologists, such as Ob/Gyns. These are the type of physicians that would have included results of OVA1 in order to evaluate a woman's ovarian adnexal mass prior to surgery.

With dual assessment (pre-surgical assessment and OVA1), sensitivity for malignancy was 92 percent, compared to only 72 percent without OVA1. Generally speaking, sensitivity refers to the percentage of individuals who have a disease which a test correctly identifies as diseased. Moreover, the combination of OVA1 and standard pre-surgical assessments correctly identified benign ovarian masses 93 percent of the time in the population studied.

Additionally, 14 of the 20 women who participated in the OVA1 trial whose cancer was missed by pre-surgical assessment would have been identified as having a malignant ovarian mass if OVA1 results also been evaluated prior to surgery.²

Does a physician always recommend surgery for women with an ovarian adnexal mass?

No. In some cases, a physician may prefer to observe a patient based on clinical and radiological evaluations. For instance, the physician may believe these evaluations indicate an ovarian adnexal mass is a cyst rather than a tumor, and surgery may not be necessary. However, for those women for whom surgery is planned, OVA1 may provide additional information so they can be referred to the most appropriate surgeon which may lead to a better treatment outcome.

¹ Earle, et, al,. Journal of the National Cancer Institute, Vol. 98, No. 3, Feb 2006, p.176
² Data on File (from package insert, Vermillion Inc.)