AUSTIN, Texas, September 29, 2016 — ASPiRA LABs, a Vermillion company (NASDAQ: VRML), today announced a major contract agreement with CareFirst BlueCross BlueShield for their U.S. FDA cleared ovarian cancer risk assessment test, OVA1. CareFirst serves over three million patients throughout Maryland and Washington, D.C., and Virginia and the area has the greatest population density in the US.
“We are pleased to announce CareFirst BlueCross BlueShield contract agreement for OVA1,” said Valerie Palmieri, President and CEO of Vermillion, Inc. “This is our fourth recent announcement of new managed care contracts as we continue to expand our reach in our key strategic market areas.”
“The mortality rate of ovarian cancer has not changed in 40 years, even following the introduction of CA125. Given the FDA safety statement on Ovarian Cancer Screening, expanding coverage and increasing access to OVA1 for women with a pelvic mass is vital to ensuring optimal care for patients nationwide. Days and weeks matter with Ovarian Cancer. Treatment for two thirds of women with ovarian cancer does not follow the appropriate carepathway. OVA1 can change this from this onset and give piece of mind for patients with OR without disease.”
Links to multiple clinical studies showing OVA1’s strong performance over CA125 for earlier and improved detection can be found on our website:
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 with 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.
- 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.
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