Vermillion markets a novel blood test to aid in the process of diagnosing ovarian cancer. Each year in the US, more than one million ovarian masses are detected and 300,000 suspicious masses are surgically removed. Yet, ovarian cancer is rarely caught in early stages and has the highest mortality rate of all gynecological cancers. Vermillion’s OVA1 test measures 5 serum biomarkers and computes a cancer risk score using a proprietary alogrithm. A clinical study assessing the diagnostic accuracy of the system found that use of OVA1 increased a physician’s sensitivity for detecting ovarian malignancy from 74% to 96%. The CA125 test, another diagnostic test to detect ovarian cancer, has a 50% false negative rate in early-stage malignancy. Vermillion has conducted a comparative study, showing that OVA1 was a more sensitive diagnostic test than CA125. The Company has a new management team in place and is currently testing a next-generation diagnostic system, OVA2, with FDA 510(k) clearance anticipated in the second half of 2015.

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