Second generation Overa test for ovarian cancer receives EU CE mark approval-Vermillion

Vermillion announced registration of the CE mark and clearance to market the next generation of Vermillion's OVA1 test in the European Union, for detecting risk of malignancy in ovarian cancer. The new test, previously referred to as OVA2, has been trademarked Overa.

Overa is a simple blood test to help physicians assess the likelihood of ovarian cancer in connection with a suspicious pelvic mass. It is not a screening test; rather, Overa is to be used together with a physician's overall clinical assessment to help guide pre-surgical risk assessment and decision-making.

Key findings for Overa compared to OVA1 include a significant improvement in specificity at 69%, a 28% improvement versus OVA1. This improvement translated into 33% fewer benign positives compared with OVA1. In addition, the positive predictive value is increased from 31% (OVA1) to 40% (Overa), an improvement of 29% in a head to head comparison with the same patient population, along with a 20% improvement in overall clinical accuracy. OVA2 maintains the same high sensitivity as OVA1 at approximately 91%, and the negative predictive value was also equivalent at 97%.