About Vermillion 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 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 to help physicians assess the risk of ovarian cancer prior to surgery and as a result provide 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 (CI). As a result, false negatives were reduced from 25% for CI, to 4% with OVA1 plus CI, a reduction of 83%
- In a study focused on early-stage 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%
- Overa, cleared by FDA on March 18, 2016, measures the levels of five proteins found in the blood and then uses a second-generation OvaCalc ® algorithm 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.
Investor Relations Contact:Michael WoodLifeSci Advisors LLCTel firstname.lastname@example.org