AUSTIN, Texas, July 19, 2016 — ASPiRA LABS, a Vermillion company (NASDAQ: VRML), today announced an agreement with Priority Health Managed Benefits, a Michigan healthcare insurance company, for coverage of ASPiRA LABS’ ovarian cancer risk assessment test, OVA1.
“We are pleased to announce OVA1 payer coverage with Priority Health,” said Valerie Palmieri, President and CEO of Vermillion, Inc. “A positive ovarian cancer outcome starts with early detection and the right treatment, at the right time, for the right patient, and results in improved healthcare efficiencies. The mortality rate of ovarian cancer has not changed in 40 years, even following the introduction of CA125. Expanding access to OVA1 is key to our fundamental mission to serve women at an elevated risk for ovarian cancer. This contract is part of our campaign to pursue managed care coverage agreements throughout 2016. We hope to expand OVA1 test adoption, further build our data repository and expansion of our clinical studies to demonstrate the “total cost of care” benefit of OVA1 to healthcare systems.”
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, discovers, develops, and delivers innovative diagnostic and technology tools that help women conquer serious diseases. The company’s initial in vitro diagnostic test, OVA1®, was the first FDA-cleared, protein-based In Vitro Diagnostic Multivariate Index Assay, and represented a new class of software-based liquid biopsy in vitro diagnostics. In March 2016 Vermillion received FDA clearance for Overa™, a second generation OVA1 test with significantly improved specificity and ease of use. For additional information, including published clinical trials, visit www.vermillion.com.
About OVA1® and Overa™
- OVA1 is a proprietary FDA-cleared blood test designed to help physicians assess the risk of ovarian cancer prior to surgery, facilitating more effective referral of high risk patients to a specialist (gynecologic oncologist) for surgical treatment.
- 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. As a result, false negatives were reduced from 25% for clinical impression alone, to 4% with OVA1 plus clinical impression, a reduction of 83%.
- In a study focused on early-stage ovarian cancer detection, 31% of cases were missed by clinical impression alone. This was reduced to 5% when OVA1 was added to clinical impression, a reduction of 85%.
- OVA1 has shown clinical utility in increasing the rate of referrals of malignant adnexal masses to gynecologic oncologists. The increased involvement of specialists may lead to increased National Comprehensive Cancer Network-adherent cancer care, which is associated with improved cancer outcomes, including overall survival. In a study focused on specialist involvement in ovarian cancer treatment, 94% of patients with an elevated-risk OVA1 result who had primary ovarian malignancies were appropriately referred to a gynecologic oncologist.
- Overa, cleared by the FDA on March 18, 2016, measures the levels of five proteins found in the blood and then uses a second-generation algorithm, incorporated into the OvaCalc® software, to stratify risk. A woman’s risk of cancer is measured by using a 0-10 scale with a single cut-off point of 5 eliminating the ambiguity in determining menopausal status. A high Overa score is not a diagnosis of cancer, rather it indicates an increased risk of malignancy when used as intended.
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