AUSTIN, Texas, Oct. 25 /PRNewswire-FirstCall/ -- (Nasdaq : VRML ) -- 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, today presented data demonstrating the high sensitivity of the OVA1 test at the 13th Annual International Gynecologic Cancer Society Meeting being held in Prague, October 23-26.
Dr. Ueland's presentation demonstrated that OVA1 had sensitivity for ovarian cancer of 92.5%, as compared to 68.9% for CA125 using cutoffs established in the ACOG criteria for adnexal mass evaluation and 77.0% for CA125 using cutoffs in the modified ACOG criteria. Additionally, OVA1 detected 23/24 stage I epithelial ovarian cancers (EOC) and 17/17 stage II epithelial ovarian cancer, for an overall sensitivity of 97.6% for early stage EOC, as compared to 65.9% for CA125 using the ACOG cutoffs. The improvement in sensitivity was even greater among premenopausal women; for OVA1, sensitivity for early stage EOC was 92.9% and for CA125, sensitivity was 35.7%. Overall, OVA1 detected 76% of malignancies missed by CA125, including all advanced stage malignancies.
"Studies show that women have more favorable outcomes when surgery for ovarian cancer is performed by a gynecologic oncologist," explained Dr. Ueland. "The current research further demonstrates that OVA1 will not only help identify more women with ovarian cancer for referral, but can give them greater confidence that their ovarian tumor is benign."
"Because of the high mortality from ovarian cancer, clinical sensitivity for malignancy is paramount," said Gail S. Page, Chair and Chief Executive Officer of Vermillion, Inc. "These data further support the clinical utility of OVA1 as an adjunctive tool to aid physicians in the assessment of women with an adnexal mass for whom surgery is planned to help them decide whether referral to a gynecologic oncologist might be appropriate."
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. OVA1™ is a trademark of Vermillion Inc. Additional information about OVA1™ can be found on the Web at http://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 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.
SOURCE Vermillion, Inc.