Vermillion Inc, a molecular diagnostics company, announced that its OVA1™ Test is now CE marked, which is a requirement for marketing the test in the European Union.
OVA1 has satisfied all certification requirements to complete its declaration of conformity.
"The CE mark addition to OVA1 represents a significant milestone for Vermillion which will pave the way for global commercialization," said Gail S. Page, CEO and Chairperson of the Board of Directors of Vermillion. "The CE mark is recognized internationally as an indicator of high product quality."
OVA1 is a qualitative serum test that combines the results of five immunoassays into a single numerical score. It is indicated for women who meet the following criteria: over age 18, ovarian adnexal mass present for which surgery is planned, and not yet referred to an oncologist. The test utilizes five well-established biomarkers – Transthyretin (TT or prealbumin), Apolipoprotein A-1 (Apo A-1), beta 2-Microglobulin (beta 2M), Transferrin (Tfr) and Cancer Antigen 125 (CA 125 II) – and a proprietary FDA-cleared software device to determine the likelihood of malignancy in women with pelvic mass for whom surgery is planned.