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 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

How is OVA1 different than CA-125?

OVA1 is the only blood test clearedby 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.

What type of clinical data supports OVA1?

Vermillion conducted a prospective, double-blind clinical trial, which included 27 demographically mixed sites representative of institutions where ovarian tumor subjects may undergo a gynecological examination. OVA1 was validated using blood samples from 516 women, both pre- and post-menopausal, 161 of whom had a pathology-determined malignancy.

What specifically do the guidelines say about referring women to a gynecologic oncologist?

Guidelines from the American College of Obstetricians and Gynecologists (ACOG), the Society of Gynecologic Oncologists (SGO), and the National Comprehensive Cancer Network (NCCN) recommend that women with an ovarian adnexal mass that is suspicious for cancer be under the care of a gynecologic oncologist.

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."³[Full Article]

ACOG/SGO Joint Opinion Guidelines: provides guidance for referral of women with ovarian adnexal masses to gynecologic oncologists. Specifically, the guidance says that women with suspected ovarian adnexal masses should be operated upon by gynecologic oncologists.

NCCN: The National Comprehensive Cancer Network in its Practice Guidelines in Oncology v1.2.2010, recommends that a “suspicious /palpable pelvic mass detected on abdominal/pelvic exam and/or ascites, abdominal distension and/or symptoms such as bloating, pelvic or abdominal pain,” and other symptoms ... “without any obvious source of malignancy” should go through a “workup” consisting of “ultrasound and/or abdominal / pelvic CT.” The guidelines further suggest that patients should be directed to a gynecologic oncologist for evaluation.

Does the Society of Gynecologic Oncologists (SGO) support the use of OVA1?

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.” [full SGO statement]

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.)¹ Earle, et, al,. Journal of the National Cancer Institute, Vol. 98, No. 3, Feb 2006, p.176
³ The Role of the Obstetrician-Gynecologist in the Early Detection of Epithelial Ovarian Cancer.  Committee Opinion No.477. American College of Obstetricians and Gynecologists. Obstet Gynecol; 117:742-6