Vermillion and Quest Diagnostics Sign Agreement to Make OVA1Â® Available in India
AUSTIN, Texas, April 4, 2011 /PRNewswire/ — (Nasdaq: VRML) – Vermillion, a molecular diagnostics company, today announced that it has signed an agreement with Quest Diagnostics to make OVA1 available in India. The companies are targeting a launch in the second quarter of 2011. Additionally, at the International Gynecologic Cancer Society (IGCS) regional meeting held in New Delhi April 2-3, 2011, Dr. Fred Ueland presented data demonstrating the high sensitivity for ovarian malignancy of OVA1 in combination with ultrasound.
“We are pleased to sign this agreement to make this important new test available to women outside the United States. India represents an outstanding market opportunity where there are approximately 350 million women,” said Gail S. Page, President and CEO of Vermillion, Inc. “Vermillion is now poised for growth both domestically and internationally as we continue to develop our international strategy in concert with the efforts already underway in the US.”
OVA1 is the first protein-based in vitro diagnostic multi-variate index assay (IVDMIA), a new class of state of the art software-based diagnostics, cleared by the FDA. The test utilizes five well-established biomarkers — Transthyretin (TT or prealbumin), Apolipoprotein A-1 (Apo A-1), Beta2-Microglobulin (Beta2M), Transferrin (Tfr) and Cancer Antigen 125 (CA 125 II) — and proprietary software to determine the likelihood of malignancy in women with an ovarian mass for whom surgery is planned.
Dr. Ueland’s oral presentation highlighted the sensitivity of ultrasound and OVA1 when used to evaluate suspicious ovarian masses. OVA1 had sensitivity for malignancy of 91% and when used in conjunction with ultrasound, sensitivity for malignancy was 97%. Fred Ueland, M.D. is Associate Professor of Gynecologic Oncology at the University of Kentucky’s Markey Cancer Center, and was principal investigator of the multi-center OVA1 clinical trial.
Quest Diagnostics operates a state-of-the-art, 65,000 square foot facility in Gurgaon (in the National Capital Region of India) that offers more than 700 tests using advanced technology, and quality standards that adhere to the global best practices. Quest Diagnostics is a global leader in diagnostic testing and women’s health.
OVA1 is the first protein-based in vitro diagnostic multi-variate index assays (IVDMIA), a new class of state of the art software-based diagnostics, cleared by the FDA. The test utilizes five well-established biomarkers — Transthyretin (TT or prealbumin), Apolipoprotein A-1 (Apo A-1), Beta2-Microglobulin (Beta2M), Transferrin (Tfr) and Cancer Antigen 125 (CA 125 II) — and proprietary software to determine the likelihood of malignancy in women with ovarian mass for whom surgery is planned.
OVA1 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. It is an aid to further assess the likelihood that malignancy is present when the physician’s independent clinical and radiological evaluation does not indicate malignancy. The test should not be used without an independent clinical/radiological evaluation and is not intended to be a screening test or to determine whether a patient should proceed to surgery. Incorrect use of the OVA1 Test carries the risk of unnecessary testing, surgery, and/or delayed diagnosis.
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.
About Quest Diagnostics:
Quest Diagnostics (NYSE:DGX) is the world’s leading provider of diagnostics testing, information and services that patients and doctors need to make better health care decisions. The company offers the broadest access to diagnostic testing services through its network of laboratories and patient service centers, and provides interpretive consultation through its extensive medical & scientific staff. Quest Diagnostics is a pioneer in developing innovative diagnostic tests and advanced healthcare information technology solutions that help improve patient care. Quest Diagnostics began operations in India in 2008 by setting up a state-of-the art 65,000 sq. ft lab in Gurgaon. Additional company information is available at www.questdiagnostics.in
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.