Vermillion Inc was incorporated on California on December 9, 1993. The Company is engaged in discovery, development and commercialization of novel high-value diagnostic tests that help physicians diagnose, treat and improve outcomes for patients with gynecologic cancers and related diseases. The Company concentrates its development of novel diagnostic tests in the fields of gynecologic oncology and women's health, with the initial focus on guiding the referral of women with ovarian cancer to a cancer specialist for surgery. Its commercial efforts include direct marketing and sales activities as well as partnerships with main companies in women's health. Its main product, OVA1, is an ovarian cancer test system that integrates a software algorithm and blood test cleared by the FDA in September 2009. OVA1 was launched in March 2010 by Quest Diagnostics under the terms of a strategic alliance agreement that the Company terminated in August 2013. In September 2010, it announced that OVA1 had obtained a CE mark, a requirement for marketing the OVA1 test in the European Union. OVA1 has satisfied all certification requirements to complete its declaration of conformity. OVA1 addresses a clear unmet clinical need, namely the pre-surgical identification of women who are at high risk of having a malignant ovarian tumor. It has two ongoing R&D-sponsored initiatives to support OVA1 market development and adoption as an improved standard of care in the pre-surgical triage and evaluation of adnexal masses. The first is a main new clinical study of OVA1, focused on its performance in the predominantly pre-menopausal non-gynecologic oncologist patient population. The second R&D initiative supporting OVA1 is a series of Vermillion-assisted, independent clinical research studies of OVA1. Through this program, Vermillion offers limited support for well-qualified principal investigators in the form of materials, testing services, and scientific consulting. As a result, the Company is currently in discussion with various potential investigators to support new research publications on OVA1s clinical utility, cost-effectiveness, and potential line extensions. The Company competes with companies in the United States and abroad that are engaged in the development and commercialization of novel biomarkers. Its activities related to diagnostic products are subject to regulatory oversight by the FDA under provisions of the Federal Food, Drug and Cosmetic Act and regulations thereunder, including regulations governing the development, marketing, labeling, promotion, manufacturing and export of its products.
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