On November 12, 2009, Vermillion announced that the U.S. Patent Office has issued a patent for the use of biomarkers for detecting ovarian cancer. The patent covers biomarker combinations for both the diagnosis and management of ovarian cancer and covers measurement of the markers by a variety of methods, including mass spectrometry and immunoassay approaches.
Vermillion's OVA1 Test 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 eighteen, 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), Beta2-Microglobulin (Beta2M), Transferrin (Tfr) and Cancer Antigen 125 (CA 125 II) --- and a proprietary algorithm to determine the likelihood of malignancy in women with pelvic mass for whom surgery is planned.