AUSTIN, Texas, March 7, 2011 /PRNewswire/ -- (Nasdaq: VRML) -- Vermillion is pleased to announce the presentation of two studies demonstrating the high sensitivity of OVA1® during the 42nd Annual Meeting on Women's Cancer of the Society of Gynecologic Oncologists, March 6-9, 2011 in Orlando, Florida. The presentations were as follows:
Rachel, W. Miller, MD, Clinical Fellow in the Department of Gynecologic Oncology, University of Kentucky Healthcare Markey Cancer Center
"OVA1 improves the sensitivity of the ACOG referral guidelines for an ovarian mass"
Dr. Miller's presentation reported the performance of the current ACOG guidelines and the modified ACOG criteria in the prospective multi-center OVA1 clinical trial. Replacing CA125 with OVA1 in these guidelines would have improved overall sensitivity for ovarian malignancy from 77% to 94%. This improvement held across both pre- and postmenopausal women and all stages of malignancy. In particular, sensitivity for malignancy among premenopausal women improved from 58% to 91% and from 47% to 88% for premenopausal women with early stage ovarian cancer.
Fred Ueland, M.D., Associate Professor of Gynecologic Oncology at the University of Kentucky's Markey Cancer Center, and principal investigator of the multi-center OVA1 clinical trial, and Dr. Zhen Zhang from the Department of Pathology of Johns Hopkins Medical Institutions
"OVA1 Has High Sensitivity in Identifying Ovarian Malignancy Compared to Preoperative Assessment and CA125"
Dr. Ueland and Dr. Zhang's presentation evaluated subjects enrolled in the prospective OVA1 clinical trial. The physician's pre-operative assessment resulted in a sensitivity of 75.2% which would have improved significantly to 95.7% with the addition of OVA1. Dr. Ueland and Dr. Zhang conclude that "when combined with a preoperative assessment, OVA1 can help determine the risk of malignancy for an ovarian tumor before surgery, and facilitate decisions about referral to a gynecologic oncologist."
"These additional data provide further support for the clinical utility of OVA1," stated Eric T. Fung, MD, PhD. Vermillion's Senior Vice president and Chief Science Officer. "In particular, when OVA1 is used as part of a comprehensive workup per ACOG/SGO recommendations, sensitivity for ovarian malignancy may increase substantially."
Vermillion, Inc. 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 oncology, hematology, cardiology and women's health. Additional information about Vermillion can be found on the Web at www.vermillion.com.
OVA1® is a qualitative serum test that combines the results of five immunoassays into a single numerical score. It is indicated for women who meet the following criteria: over age 18, ovarian adnexal mass present for which surgery is planned, and not yet referred to an oncologist. The test utilizes five well-established biomarkers - Transthyretin (TT or prealbumin), Apolipoprotein A-1 (Apo A-1), beta 2-Microglobulin (beta 2M), Transferrin (Tfr) and Cancer Antigen 125 (CA 125 II) - and a proprietary FDA-cleared software device to determine the likelihood of malignancy in women with pelvic mass for whom surgery is planned. Additional information about OVA1® can be found on the Web at www.ova-1.com.
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 payors such as private insurance companies and government insurance plans; (5) uncertainty that Vermillion will successfully license or otherwise successfully partner with third parties to commercialize its future products; (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.
SOURCE Vermillion, Inc.