American Journal of Obstetrics & Gynecology Publishes New Clinical Study Showing Positive Performance of Vermillion's Ovarian Cancer Test, OVA1 Triage Sensitivity Significantly Improved without a Predicted Increase in Rate of Specialist Referral

WASHINGTON, Nov. 12, 2013 /PRNewswire/ -- A new clinical study published in The American Journal of Obstetrics & Gynecology has reported superior sensitivity of OVA1® for presurgical triage of ovarian cancer in a large intended-use population, compared with commonly used risk assessment methods.

The new study compared OVA1 performance to benchmark triage methods, within a combined cohort of 770 ovarian mass surgery patients (including 164 malignancies) from two independent but related OVA1 pivotal trials conducted in 2007 and 2012. The study also compared the actual rate of patient referral from non-specialist physicians to gynecologic oncologists (GO's) with rates predicted from clinical assessment, OVA1, CA125 or from the modified-American College of Obstetricians and Gynecologists (mod-ACOG) guidelines. Vermillion, Inc. (NASDAQ: VRML), the multivariate diagnostics company which developed and currently markets the test, reported the findings today at the American Association of Gynecologic Laparoscopists "42nd AAGL Global Congress on Minimally Invasive Gynecology."

Dr. Robert E. Bristow, lead author of the study and director of Gynecologic Oncology Services at UC Irvine Healthcare, commented: "Despite widely endorsed treatment standards published by the National Comprehensive Cancer Network, several studies published earlier this year show that only a minority of ovarian cancer patients actually receive treatment by the doctors and hospitals best equipped to care for them. Our new publication shows that the FDA-cleared OVA1 test achieves significantly higher sensitivity than two commonly used methods. And despite lower specificity, the referral rates predicted by OVA1 were roughly comparable to actual clinical practice."

METHODS AND FINDINGS

Physicians participating in the study were required to predict whether ovarian masses were malignant or benign following clinical assessment. The clinical assessment stipulated physical examination and imaging, family history, and laboratory tests (including CA125, if used). OVA1 performance as a risk stratification test was compared with clinical assessment, Predicted and actual referral rates were analyzed and predictions were compared with final pathology results.

Clinical assessment correctly predicted 120 of 164 malignancies (73.2%), while 44 were mistakenly predicted to be benign (26.8%). Among three risk-stratification methods compared, OVA1 showed the highest sensitivity (148/164, or 90.2%). OVA1 sensitivity was significantly higher than either benchmark method: sensitivity of the mod-ACOG guidelines was 130/164 (79.3%) while CA125 sensitivity was 112/164 (68.4%). The number of malignancies incorrectly stratified as low risk by CA125, mod-ACOG and OVA1 was 52 (31.6%), 34 (20.7%) and 16 (9.8%), respectively.

OVA1 performance predicted an overall referral rate of 55.7%, slightly lower than the actual referral rate of 60.0% observed across all patients in the study. Despite the other risk stratification methods predicting lower overall referral rates, approximately 48-52% of patients rated as low risk were nevertheless referred in actuality. Reasons for these unexpected referrals were not evident.

"This study, focused on intended-use patients enrolled through 44 sites nationwide, found that OVA1 sensitivity was statistically superior to CA125 or the other risk stratification protocols examined," stated Dr. Donald Munroe, Vermillion's chief scientific officer and SVP of business development. "While high sensitivity and negative predictive value are diagnostic imperatives for presurgical ovarian cancer triage, the work also shed light on patient referral patterns with or without OVA1. Notably, the predicted OVA1 referral rate was comparable to actual GO referrals using physicians' usual methods. This finding suggests that OVA1's benefits may be achievable without dramatically altering overall referral rates. We now plan to transition into additional health economics, efficiency and outcomes studies with leading collaborators, which will be announced as we move forward."

The study, "Impact of a Multivariate Index Assay on Referral Patterns for Surgical Management of an Adnexal Mass," was co-authored by Dr. Bristow along with Dr. Frederick R. Ueland of the University of Kentucky, as well as investigators from The Johns Hopkins University and scientists from Vermillion.

References:

Bristow RE, Hodeib M, Smith A, et al. Impact of a multivariate index assay on referral patterns for presurgical management of an adnexal mass. Am J Obstet Gynecol 2013;209 (in press).

About American Journal of Obstetrics & Gynecology

The American Journal of Obstetrics & Gynecology (www.AJOG.org), known as "The Gray Journal," presents comprehensive coverage of the obstetrics and gynecology specialty, including maternal-fetal medicine, reproductive endocrinology/infertility, and gynecologic oncology.

About Vermillion

Vermillion, Inc. (NASDAQ: VRML) is dedicated to the discovery, development and commercialization of novel high-value diagnostic tests that help physicians diagnose, treat and improve outcomes for patients. Vermillion, along with its prestigious scientific collaborators, has diagnostic programs in gynecologic oncology and women's health.

The company's lead diagnostic, OVA1®, is a blood test for pre-surgical assessment of ovarian tumors for malignancy, using an innovative algorithmic approach. As the first FDA-cleared, protein-based In Vitro Diagnostic Multivariate Index Assay, OVA1 represents a new class of software-based diagnostics. For additional information, including published clinical trials, visit www.vermillion.com.

Forward-Looking Statements 

Certain matters discussed in this press release contain forward-looking statements that involve significant risks and uncertainties, including statements regarding Vermillion's plans, objectives, expectations and intentions. These forward-looking statements are based on Vermillion's current expectations. The Private Securities Litigation Reform Act of 1995 provides a "safe harbor" for such forward-looking statements. In order to comply with the terms of the safe harbor, Vermillion notes that a variety of factors could cause actual results and experience to differ materially from the anticipated results or other expectations expressed in such forward-looking statements. Factors that could cause actual results to materially differ include but are not limited to: (1) uncertainty as to Vermillion's ability to protect and promote its proprietary technology; (2) Vermillion's lack of a lengthy track record successfully developing and commercializing diagnostic products; (3) uncertainty as to whether Vermillion will be able to obtain any required regulatory approval of its future diagnostic products; (4) uncertainty of the size of market for its existing diagnostic tests or future diagnostic products, including the risk that its products will not be competitive with products offered by other companies, or that users will not be entitled to receive adequate reimbursement for its products from third party payers such as private insurance companies and government insurance plans; (5) uncertainty that Vermillion has sufficient cash resources to fully commercialize its tests and continue as a going concern; (6) uncertainty whether the trading in Vermillion's stock will become significantly less liquid; and (7) other factors that might be described from time to time in Vermillion's filings with the Securities and Exchange Commission. All information in this press release is as of the date of this report, and Vermillion expressly disclaims any obligation or undertaking to release publicly any updates or revisions to any such statements to reflect any change in Vermillion's expectations or any change in events, conditions or circumstances on which any such statement is based, unless required by law.

This release should be read in conjunction with the consolidated financial statements and notes thereto included in the company's most recent reports on Form 10-K and Form 10-Q. Copies are available through EDGAR at www.sec.gov.

Investor Relations Contact:
Liolios Group, Inc.
Ron Both
Tel 949-574-3860
vrml@liolios.com

SOURCE Vermillion, Inc.



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