Vermillion Approved for a $7.5M Grant by the Cancer Prevention and Research Institute of Texas

Vermillion, Inc.

, a bio-analytical solutions company focused on gynecologic disease, announced today that it has been approved for a product development grant from the Cancer Prevention and Research Institute of Texas (CPRIT) for $7.5 million, to help fund the Company's new multi-site pelvic mass registry. The grant would assist Vermillion in creating a first-in-kind clinical registry of patients undergoing evaluation, diagnosis, treatment and follow-up for pelvic masses that may lead to gynecologic malignancy. The registry would be headquartered in Austin and would be a centralized strategic asset in Vermillion's mission to improve care for ovarian cancer and other important gynecologic conditions. Receipt of the grant award is subject to execution of a grant contract on terms acceptable to both Vermillion and CPRIT and may include such terms as payment of future product royalties to CPRIT by Vermillion. This planned registry differs from previous clinical trials conducted by Vermillion for its OVA1® and OVA2 (second-generation OVA1) tests in several important ways: Patients will be enrolled at the time a suspicious pelvic mass is first identified Up to ten "hub sites" will manage patient enrollment regionally under the leadership of nationally-renowned clinical academicians Enrollment will come from a broad spectrum of naturally-presenting gynecologic diseases requiring differential diagnosis for ovarian cancer Patients will be followed and data collected longitudinally through evaluation, eventual surgery, diagnosis and early outcomes In addition to serum biomarkers, Vermillion plans to investigate imaging, other molecular markers, symptoms and clinical risk factors. Vermillion has referred to this multi-modal diagnostic approach as its "bio-analytic" technology platform The first output of the registry is expected to be a validated, semi-quantitative risk assessment algorithm that will assist physicians in managing patients at risk for ovarian cancer. The pelvic mass registry will also enable the research and development by Vermillion of intellectual property and products that can be applied to other gynecologic diseases such as early diagnosis of endometriosis, fibroids or polycystic ovaries. The registry will be co-led by Dr. Jubilee Brown from M.D. Anderson Cancer Center in Houston, Dr. Judith Wolf, Vermillion's Chief Medical Officer, and Dr. Donald Munroe, Vermillion's Chief Scientific Officer. Dr. Wolf stated, "We are honored by CPRIT's interest in investing in our vision to drive better ovarian cancer care. The unmet needs in ovarian cancer are serious and urgent, and we believe this grant would directly contribute to innovative solutions." Dr. Munroe added, "This funding would accelerate the pace at which we create this multi-product, multi-disease clinical registry. But in addition, it would catalyze Vermillion's strategic growth by funding clinical infrastructure, clinical staffing and expanded technical assets." "Our mission is to understand the pelvic mass disease pathways for both benign and malignant disease. The approval of this grant is a testament to our overall registry plan, process and our forward thinking. The approval of this grant is truly a capstone achievement for Vermillion as well as for the large population of patients it is expected to serve," said Valerie Palmieri, Vermillion's President and CEO.