AUSTIN, Texas, Aug. 19, 2015 /PRNewswire/ -- Vermillion, Inc. (NASDAQ: VRML), a bio-analytical solutions company focused on gynecologic disease, today announced additional medical policy coverage of its OVA1 test, with the decision by CareFirst Blue Cross/Blue Shield to include OVA1 in its medical policy guidelines. CareFirst Blue Cross/Blue Shield is the largest insurer in Maryland, covering 3.4 million members, which represents over 40% of total lives in the state. The announcement follows the recent positive coverage decision for OVA1 by Blue Cross/Blue Shield of Michigan in April 2015 and brings the total number of commercially covered lives for the OVA1 test to more than 16 million.
"We are pleased to see the ongoing adoption of OVA1 by significant insurance providers," said Valerie Palmieri, President and CEO of Vermillion. "We believe this decision by CareFirst to cover OVA1 further underscores the value this test brings to physicians, who rely on the results in assessing low risk and high risk of malignancy in their patients needing surgery for a pelvic mass. OVA1 is the only technology available today that allows a physician to assess the risk of malignancy for all ovarian cancer stages, all age groups and all histologic types of ovarian cancer."
Vermillion, Inc. is dedicated to the discovery, development and commercialization of novel high-value diagnostic and bio-analytical solutions that help physicians diagnose, treat and improve gynecologic health outcomes for women. Vermillion, along with its prestigious scientific collaborators, has diagnostic programs in gynecologic disease. The company's lead diagnostic, OVA1, is a blood test for pre-surgical assessment of ovarian tumors for malignancy, using an innovative algorithmic approach. As the first FDA-cleared, protein-based In Vitro Diagnostic Multivariate Index Assay, OVA1 represents a new class of software-based diagnostics. For additional information, including published clinical trials, visit www.vermillion.com.
- OVA1 is a proprietary FDA-cleared blood test to help physicians assess the risk of ovarian cancer prior to surgery and trigger the involvement of a specialist (gynecologic oncologist) for higher risk patients.
- The OvaCalc® proprietary algorithm combines five biomarker results into a single numerical "risk score" that stratifies patients into "higher risk" and "lower risk" when combined with clinical assessment.
- In two pivotal clinical trials, OVA1 plus clinical impression detected 96% of all malignancies vs. 75% for clinical impression alone. It subsequently reduced the number of malignancies missed from 25% to 4%, a reduction of 83%.
- For early-stage cancers specifically, 31% were missed by clinical impression alone. This was reduced to 5% when OVA1 was added to clinical impression, a reduction of 85%.
- Vermillion is currently developing a next-generation test, OVA2, which has an expected release in the second half of 2015.
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SOURCE Vermillion, Inc.