Vermillion have announced that it has received a $7.5 million grant from the Cancer Prevention and Research Institute of Texas to support the firm's efforts in developing a multi-site pelvic mass registry.
The registry would contain data on patients undergoing evaluation, diagnosis, treatment, and follow up for pelvic masses that may lead to gynecologic malignancy. It would collect data from 10 hub sites that would manage patient enrollment regionally.
Vermillion said that receipt of the grant is subject to execution of a contract on terms acceptable to both the firm and CPRIT, and may include such terms as payment of future product royalties to CPRIT by Vermillion.
The Austin, Texas-based firm intends to investigate symptoms and clinical risk factors, as well as serum, imaging, and other molecular biomarkers. The registry is expected to yield a "validated, semi-quantitative risk assessment algorithm that will assist physicians in managing patients at risk for ovarian cancer," according to Vermillion.
The registry is also expected to enable research and development by Vermillion of diagnostic products that could be applied to gynecologic diseases such as endometriosis, fibroids, or polycystic ovaries.
Jubilee Brown from MD Anderson Cancer Center in Houston will co-lead the registry with Vermillion Chief Medical Officer Judith Wolf and Vermillion CSO Donald Munroe.
"This funding would accelerate the pace at which we create this multi-product, multi-disease clinical registry," Munroe said in a statement. "But in addition, it would catalyze Vermillion's strategic growth by funding clinical infrastructure, clinical staffing and expanded technical assets."
Vermillion currently offers the OVA1 ovarian cancer test, which has been cleared by the US Food and Drug Administration for determining if patient adnexal masses are likely malignant or benign. The firm, however, is moving beyond its traditional proteomics-based test development.
Vermillion recently said that through its wholly owned subsidiary Aspira Labs, it is in the process of building two new laboratory-developed tests, one combining its second-generation proteomic ovarian cancer test OVA2 with patient ultrasound results, and the second combining OVA2 with data from the patient symptom registry.