U.S. Army and Vermillion to Assess Health and Economic Benefits of OVA1 as a Standard of Care
AUSTIN, Texas, April 17, 2013 /PRNewswire/ -- Vermillion, Inc. (NASDAQ: VRML), a molecular diagnostics company focused on gynecologic cancers and women's health, announced the signing of a cooperative research and development agreement (CRADA) with the U.S. Army Medical Research and Materiel Command (USAMRMC).
The agreement kicks off a project titled, "Cost Reduction Using OVA1 in a Treatment Algorithm for Adnexal Masses in Women," and follows a January 2012 decision by the U.S. Department of Defense to cover OVA1® testing. The two-phase study will investigate the cost-benefit profile of OVA1 testing as a presurgical standard of care in women with pelvic masses, and assess OVA1 clinical utility in a managed care setting.
Phase 1 will retrospectively assess medical outcomes and total cost of care to establish historical benchmarks and estimate potential benefits of OVA1 utilization. Phase 2 will involve a multi-center prospective clinical study within the Western Regional Command to assess OVA1 as a standard of care across a large sector of the U.S. Armed Forces.
An Army spokesperson for the study stated: "The Department of Defense is committed to improving and streamlining medical care for our female service members and dependent family members. And at the same time, the DoD is working hard to reduce out-of-network medical costs, avoidable travel costs and time away from family, all of which drain resources from where they are needed. We are excited by previous publications on OVA1's diagnostic performance, which suggest the potential to positively impact both of these important goals.
"With this project, we hope to measure for the first time the real-world impact of OVA1 on medical and health economic outcomes, compared with accurate and holistic benchmarks. For example, the sensitive detection of stage I ovarian cancer has always been difficult. But when appropriately detected and treated, greater than 90% complete cure rates have been reported. This is just one example of benefits we expect to see with a sensitive test like OVA1 when implemented as a standard of care across our managed care network."
Thomas McLain, president and chief executive officer of Vermillion, added: "Our clinical collaboration with the U.S. Armed Forces is an important step towards OVA1 becoming a presurgical standard of care in women with pelvic masses. They are uniquely positioned to measure the total cost of care and medical outcomes across a large patient population in a standardized and rigorous manner. And we could not ask for a research partner with a higher profile or standards of excellence."
References herein to the activities of the U.S. Army, the Department of Defense, Government investigators, a Federal laboratory or the U.S. Government does not imply an endorsement or recommendation of the products or services of Vermillion, Inc. by any U.S. Government entity.
As the Army's medical materiel developer, USAMRMC focuses on medical research, development and acquisition, and medical logistics management. USAMRMC headquarters is located at Fort Detrick, Md., and supports 12 subordinate commands and 6 executive agencies located throughout the world. https://mrmc.amedd.army.mil.
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 oncology, vascular medicine and women's health. Additional information about Vermillion can be found at www.vermillion.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 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.
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