Mercy BioAnalytics Wins FDA Clearance for Ovarian Cancer Test Study

The SOARA study—Safety in Ovarian Cancer for Average-Risk Women—represents a critical shift in the company’s regulatory roadmap. By moving into prospective clinical validation, Mercy BioAnalytics aims to generate the data necessary to support future regulatory submissions. While the FDA has previously granted the Evident test Breakthrough Device Designation, this IDE approval serves strictly as authorization to conduct the investigation rather than a final product endorsement.

The Evident test utilizes the proprietary Mercy Halo liquid biopsy platform, which analyzes extracellular vesicles in the blood to identify cancer-associated biomarkers. CEO Dawn Mattoon emphasized that the study is engineered to build the evidence base required to bring early detection to a broader population. Given that ovarian cancer is most frequently identified at advanced, less treatable stages, the development of a reliable screening tool remains a high-stakes clinical objective.