2014

American Journal of Obstetrics & Gynecology Publishes New Clinical Study Showing Positive Performance of Vermillion's OVA1 Test in Presurgical Detection of Early-Stage Ovarian Cancer Significantly Superior Early-Stage Sensitivity Shown versus CA125, Modified ACOG Guidelines or Overall Clinical Assessment in Premenopausal and Postmenopausal Women Planning Surgery

WASHINGTON, Nov. 12, 2013 /PRNewswire/ --  A new study of OVA1® clinical performance in the presurgical detection of ovarian cancer, entitled "Clinical Performance of a Multivariate Index Assay For Detecting Early-Stage Ovarian Cancer," has been published in The American Journal of Obstetrics & Gynecology.

Led by Dr. Robert E. Bristow (UC Irvine Healthcare) and Dr. Frederick R. Ueland (U. Kentucky), the new analysis focuses on presurgical detection of early-stage ovarian cancer among 1,016 ovarian mass surgery patients in two previous pivotal trials conducted in 2007 and 2012.

The study compared OVA1 performance in early-stage ovarian cancer to commonly used cancer risk assessment protocols: overall clinical assessment, the CA125 biomarker or modified-American College of Obstetricians and Gynecologists (mod-ACOG) guidelines for evaluation of suspicious pelvic masses. 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."

"Early-stage ovarian cancer constitutes an important opportunity to improve survival and care for this most deadly gynecologic cancer," said Dr. Bristow. "However, as evidenced by recent studies, most ovarian cancer patients fail to be referred to the doctors and hospitals best equipped to treat them, resulting in unfortunate consequences.

"Our new study demonstrates OVA1's ability to detect the majority of all early-stage ovarian cancers prior to surgery and thereby aid in appropriately involving a gynecologic oncologist in their care. Even among premenopausal patients where primary ovarian cancer prevalence was only 15%, clinical assessment with OVA1 detected early-stage ovarian cancer with nearly 90% sensitivity. This is a very encouraging development for diagnosis and treatment of ovarian cancer."

METHODS AND FINDINGS

As a benchmark of usual care, physicians were required to predict whether ovarian masses were malignant or benign following overall clinical assessment, which included physical examination and imaging, family history, and laboratory tests (including CA125, if used). Overall success of clinical assessment in predicting an early-stage malignancy (confirmed by pathology) was 68.6% (59 of 86 malignancies), while 31.4% were mistakenly predicted to be benign. For stage I malignancies the percent detected fell to 63.9% (39/61), with 36.1% mistakenly predicted to be benign. Adding OVA1 to clinical assessment successfully identified 95.3% of early-stage cancers (82/86) and 93.4% of stage I malignancies (57/61) – a reduction in cancers missed of 85% (early-stage) and 82% (stage I), respectively over clinical assessment alone.

Among three risk-stratification methods compared directly for early-stage cancer detection, OVA1 showed the highest sensitivity (91.9%, or 79/86). OVA1 sensitivity was significantly higher than either benchmark method: sensitivity of the mod-ACOG guidelines was 76.7% (66/86) while CA125 sensitivity was 62.8% (54/86). The number of malignancies incorrectly stratified as low risk by CA125, mod-ACOG and OVA1 was 37.2%, 23.3% and 8.1%, respectively.

Early-stage cancer detection by OVA1 was 85.7% among premenopausal patients and 94.8% among postmenopausal patients. In contrast, CA125 alone correctly classified just 35.7% in premenopausal patients and 75.9% in postmenopausal patients. Used as intended together with clinical assessment, OVA1 sensitivity was 89.3% and 98.3% for pre- and post-menopausal early-stage cancer detection.

Dr. Donald Munroe, Vermillion's chief scientific officer and SVP of business development, commented: "Knowing the importance of referring early-stage ovarian cancer to gynecologic oncologists for optimal care, we are very encouraged by this latest clinical study. OVA1 significantly outperformed the three common risk assessment protocols in detecting early-stage cancers, which present the best opportunity for favorable outcomes or cure if appropriately handled. These results highlight the potential of OVA1 to replace the inferior off label use of CA125 and improve the presurgical management of ovarian cancer, which benefits patients, physicians and payers alike."

References:

Longoria TC, Ueland FR, Zhang Z, et al. Clinical performance of a multivariate index assay for detecting early-stage ovarian cancer. 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 our most recent reports on Form 10-K and Form 10-Q. Copies are available through the SEC's Electronic Data Gathering Analysis and Retrieval system (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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