FDA Clears IDE for Mercy's Ovarian Cancer Blood Test Trial
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Waltham, Mass. – September 21, 2026 -- The U.S. Food and Drug Administration has approved Mercy BioAnalytics' Investigational Device Exemption application for its Evident Ovarian Cancer Screening Test, clearing the way for the company's pivotal SOARA Clinical Validation Study pending Institutional Review Board sign-off.
FDA clears IDE application for Mercy's Evident Ovarian Cancer Screening Test
The approval permits Mercy to launch the prospective SOARA study -- Safety in Ovarian Cancer for Average-Risk Women, Analysis -- to evaluate the safety of the blood-based test in average-risk women. The IDE clearance does not constitute FDA approval or clearance of the Evident test itself, but authorizes the specified clinical investigation to proceed.