Vermillion, Inc. has 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."