AUSTIN, Texas — Vermillion, Inc. (NASDAQ: VRML), a bio-analytical solutions company focused on gynecologic disease, exited 2015 with substantial coverage for its OVA1 diagnostic test, which helps physicians assess patients for the risk of ovarian cancer prior to pelvic mass surgery. OVA1 payor coverage now extends to approximately 33 million lives nationally and includes Medicare beneficiaries in the 14 states covered by Novitas, Blue Cross/Blue Shield coverage in Louisiana, Arkansas, Michigan and CareFirst of Maryland, as well as recent coverage by Medi-Cal and AvMed.
In addition, approximately 80 million in network lives are also covered for OVA1 through strategic national PPO networks, including Multiplan, Three Rivers and the Stratos provider networks. “We are very pleased with the march of positive coverage we have developed for OVA1 during 2015,” said Valerie Palmieri, CEO and President of Vermillion. “We believe these results underscore the value the test brings to physicians, who rely on our liquid biopsy test to provide early detection in assessing pelvic mass patients with low risk or high risk of malignancy prior to surgery. We look forward to adding to our covered lives as we drive to our goal of a first national payor in 2016.”
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 in the United States, OVA1, is a blood test for pre-surgical assessment of ovarian tumors for malignancy, using an innovative algorithmic approach. OVA1, which was the first FDA-cleared, protein-based In Vitro Diagnostic Multivariate Index Assay, 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, 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
This press release contains forward-looking statements, as that term is defined in the Private
Litigation Reform Act of 1995, that involve significant risks and uncertainties, including with
respect to the expected release of Overa. Words such as “may,” “expects,” “intends,”
“anticipates,” “believes,” “estimates,” “plans,” “seeks,” “could,” “should,” “continue,” “will,”
“potential,” “projects” and similar expressions are intended to identify forward-looking
statements. The forward-looking statements contained in this press release are based on
Vermillion’s expectations as of the date of this press release. 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 from those projected in such forward-looking statements include but
are not limited to: (1) Vermillion’s ability to obtain any regulatory approval required for its
future diagnostic products; (2) Vermillion’s or its suppliers’ ability to comply with FDA
requirements for production, marketing and post market monitoring of its products; and (3)
other factors that are described in Vermillion’s Form 10-Q for the quarter ended September 30,
2015 filed with the Securities and Exchange Commission (the “SEC”). Vermillion expressly
disclaims any obligation to update, amend or clarify any forward-looking statements to reflect
events, new information or circumstances occurring after the date of this press release, except
as required by law.
Investor Relations Contact:
LifeSci Advisors LLC