AUSTIN, Texas, December 1, 2015 — Vermillion, Inc. (NASDAQ: VRML), a bio-analytical solutions company focused on gynecologic disease, today announced additional medical policy coverage for OVA1, with Medi-Cal, California’s Medicaid program. Medi-Cal is now supporting OVA1 in its medical policy guidelines. Medi-Cal covers over 12.6 million beneficiaries, which represent approximately a third of the covered lives in California.
“We are very pleased with Medi-Cal’s positive coverage of OVA1,” said Valerie Palmieri, President and CEO of Vermillion. “We believe that this underscores the value the test brings to physicians, who rely on our liquid biopsy test to help assess low risk and high risk of malignancy for pelvic mass patients prior to surgery. This is an historic moment for the women of California in detecting ovarian cancer for all stages, all ages and all ovarian cancer types. More importantly, however, this decision helps California physicians provide the same standard of care for Medicaid patients as for commercially covered patients.”
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 diagnostics in the United States, OVA1, and in the European Union, Overa®, are blood tests for pre-surgical assessment of ovarian tumors for malignancy, each using an innovative algorithmic approach. Overa and OVA1, which was the first FDA-cleared, protein-based In Vitro Diagnostic Multivariate Index Assay, represent 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, Overa, which has an expected release in H1 2016, subject to FDA clearance.
• Overa is currently under review by the FDA and has received CE marking from the European Union
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