NEW YORK (GenomeWeb News) – Vermillion has signed a cooperative research and development agreement, or CRADA, with the US Army Medical Research and Materiel Command for the evaluation of the OVA1 ovarian cancer diagnostic test, Vermillion announced today.
The project, which follows a decision by the Army to cover the OVA1 test in January 2012, will be carried out in two phases to assess the cost-benefit profile of Vermillion's test as a presurgical standard of care in women with pelvic masses and to evaluate OVA1's clinical utility in a managed care setting.
In the first phase, medical outcomes and total cost of care will be retrospectively assessed to establish historical benchmarks and estimate the potential benefits of using OVA1, Vermillion said. A multicenter prospective clinical trial will be conducted in the second phase within the Western Regional Command to evaluate the test as a standard of care across a large sector of the US Armed Forces.
An Army spokesperson for the study said in a statement, "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.
"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," the spokesperson added.
Financial and other terms of the CRADA were not disclosed.