AUSTIN, Texas, March 14, 2011 /PRNewswire/ -- (Nasdaq: VRML) –Vermillion, a molecular diagnostics company, announced today the inclusion of OVA1® as part of the recently published ACOG/SGO committee opinion. In the March edition of Obstetrics and Gynecology, the American College of Obstetricians and Gynecologists (ACOG) and Society of Gynecologic Oncologists (SGO) published an update committee opinion on the role of the obstetrician-gynecologist in the early detection of epithelial ovarian cancer.(1) This updates the original opinion, which was published in 2002.
Significantly, the updated ACOG/SGO opinion cites the FDA clearance of OVA1 and indicates that OVA1 "appears to improve the predictability of ovarian cancer in women with pelvic masses." Although OVA1 is not intended to be a screening test, it "may be useful for evaluating women with a pelvic mass."
Dr. Beth Y. Karlan, M.D. comments, "Using OVA1 to better triage women with a pelvic mass may lead to improvement in outcomes, such as the well-documented improvement in survival among women with cancer who are referred to a gynecologic oncologist for ovarian cancer surgery and treatment, and more streamlined care with possible cost savings if that referral is not necessary."
Dr. Karlan is Director of the Women's Cancer Program at the Samuel Oschin Comprehensive Cancer Institute at Cedars-Sinai Medical Center and she holds the Board of Governors Chair in Gynecologic Oncology. Dr. Karlan also is Professor of Obstetrics and Gynecology at the Geffen School of Medicine at the University of California, Los Angeles (UCLA). She was President of the Society of Gynecologic Oncologists in 2005.
"We are very encouraged by the Committee's recent update," states Gail S. Page, President and CEO of Vermillion, Inc. "This supports our belief in the utility of OVA1 and the unmet medical need it fills. Additionally, we believe the positive mention is a critical step towards expanding awareness and usage of OVA1 within the physician community."
(1) 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 2011; 117:742-6
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.