The primary aim of the study was to determine the ability of its proprietary OvaCalc algorithm to estimate the risk of malignancy in pre and postmenopausal women who are scheduled for surgery with an ovarian mass.
The data demonstrates that the OvaCalc algorithm can effectively identify women with a higher likelihood of malignancy. Within the study population, the OvaCalc algorithm also detected 90% of Stage I epithelial ovarian cancer cases and 100% of stage 2-4 cancers while maintaining a greater than 90% negative predictive value among both premenopausal and postmenopausal patients, the company said.
Gail Page, president and CEO of Vermillion, said: We are extremely pleased with the significant results of the OVA1 prospective clinical trial. A major strength of the OVA1 prospective clinical trial was its inclusion of patients seen at a variety of clinical settings where the intended patient population typically undergoes a gynecological examination with radiological and clinical testing prior to surgical intervention.
The 27 sites were demographically mixed to include, for example, large and small medical centers (universities/community hospitals), small gynecology/obstetrics groups, gynecology/oncology practices, and subjects from HMO groups. This study demonstrated with statistical significance the effectiveness of the OVA1 test in estimating the risk of malignancy in pre and postmenopausal women who are scheduled for surgery with an ovarian mass.