AUSTIN, Texas, May 16, 2016 — Vermillion, Inc., a bio-analytical solutions company today announced positive top line results from a study entitled, “Clinical Performance Comparison of Two IVDMIAs for Pre-Surgical Assessment of Ovarian Cancer Risk”, presented at the annual meeting of American Congress of Obstetricians and Gynecologists (ACOG), taking place May 14th thru May 17th in Washington DC. Overa™ is Vermillion’s FDA-cleared second-generation version of the OVA1 blood test, used for pre-surgical assessment of ovarian cancer risk in women undergoing surgery for an ovarian (adnexal) mass. ROMA™ (Risk of Ovarian Malignancy Algorithm) is the only other ovarian cancer triage test that has been cleared by FDA.
Overa and ROMA tests were performed on serum from 993 prospectively-enrolled patients who underwent adnexal surgery, the largest head-to-head clinical comparison of two FDA-cleared ovarian cancer triage tests conducted to date. The Overa and ROMA biomarkers were run on the Roche cobas® platform, and high- or low-risk results were determined using the Overa cutoff of 5 and Roche’s ROMA Fact Sheet cutoffs for pre-menopausal or post-menopausal women.
Dr. Lee Shulman, who was first author of the study and serves as Chief of the Division of Obstetrics and Gynecology-Clinical Genetics at Northwestern University in Chicago, IL, stated, “We were especially interested in comparing false negative rates head-to-head with different triage tests in the same patients, since reliable referral of ovarian cancer to specialists is crucial to optimal care and outcomes. Both Overa and ROMA detected more cancers than CA125, which missed almost 30% of all malignancies and almost 40% of early stage cancers. But overall, ROMA missed 51 of the 245 malignancies in this study, including 20 of 84 early-stage ovarian cancers. By comparison, Overa missed 22 malignancies overall and 8 early-stage malignancies – 60% fewer than ROMA.”
Vermillion’s Chief Medical Officer, Dr. Judith Wolf, added, “FDA-cleared tests offer tremendous potential to improve the effectiveness of pre-surgical ovarian cancer risk assessment for women facing surgery for an ovarian mass. The single most important performance measure is false negative rate. Failure to detect a malignancy may result in surgery and treatment by non-specialists, which has been shown to significantly reduce the rate of survival. We are excited by these preliminary results and look forward to publication in a peer-reviewed journal in the near future.”
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 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 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.
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