Vermillion, a molecular diagnostics company, today announced that it has signed an agreement with Quest Diagnostics to make OVA1 available in India. The companies are targeting a launch in the second quarter of 2011. Additionally, at the International Gynecologic Cancer Society (IGCS) regional meeting held in New Delhi April 2-3, 2011, Dr. Fred Ueland presented data demonstrating the high sensitivity for ovarian malignancy of OVA1 in combination with ultrasound.
"We are pleased to sign this agreement to make this important new test available to women outside the United States. India represents an outstanding market opportunity where there are approximately 350 million women," said Gail S. Page, President and CEO of Vermillion, Inc. "Vermillion is now poised for growth both domestically and internationally as we continue to develop our international strategy in concert with the efforts already underway in the US."
OVA1 is the first protein-based in vitro diagnostic multi-variate index assay (IVDMIA), a new class of state of the art software-based diagnostics, cleared by the FDA. 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 proprietary software to determine the likelihood of malignancy in women with an ovarian mass for whom surgery is planned.
Dr. Ueland's oral presentation highlighted the sensitivity of ultrasound and OVA1 when used to evaluate suspicious ovarian masses. OVA1 had sensitivity for malignancy of 91% and when used in conjunction with ultrasound, sensitivity for malignancy was 97%. Fred Ueland, M.D. is Associate Professor of Gynecologic Oncology at the University of Kentucky's Markey Cancer Center, and was principal investigator of the multi-center OVA1 clinical trial.
Quest Diagnostics operates a state-of-the-art, 65,000 square foot facility in Gurgaon (in the National Capital Region of India) that offers more than 700 tests using advanced technology, and quality standards that adhere to the global best practices. Quest Diagnostics is a global leader in diagnostic testing and women's health.