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.
No FDA-approved ovarian cancer screening test currently exists on the market
Ovarian cancer remains among the most lethal gynecologic cancers, frequently diagnosed at advanced stages due to the absence of an approved screening tool. FDA previously granted Breakthrough Device Designation to Mercy's ovarian cancer test, a status reserved for technologies addressing unmet medical needs.
Test runs on Mercy's patented Halo liquid biopsy platform
The Evident test is powered by Mercy's Mercy Halo liquid biopsy platform, which uses biomarker colocalization to analyze blood-based extracellular vesicles and particles carrying cancer-associated signatures from their cells of origin. "FDA approval of our IDE application is an important milestone in advancing the Evident Test through the regulatory review process," said Dawn Mattoon, Ph.D., Chief Executive Officer of Mercy BioAnalytics.
The SOARA study is expected to support Mercy's ongoing clinical and regulatory program for the Evident Ovarian Cancer Screening Test.