WALTHAM, Mass., Sept. 21, 2026 /PRNewswire/ — Mercy BioAnalytics, Inc. (“Mercy” or the “Company”), a pioneer in blood-based early cancer detection, today announced that the U.S. Food and Drug Administration (“FDA”) has approved the Company’s Investigational Device Exemption (IDE) application for the Evident™ Ovarian Cancer Screening Test. The approval allows Mercy to use the test in its pivotal SOARA Clinical Validation Study, a prospective clinical study designed to evaluate the safety of the test when used for ovarian cancer screening in average-risk women, following Institutional Review Board (IRB) approval.
The study is expected to support the Company’s ongoing clinical and regulatory program for the Evident Ovarian Cancer Screening Test.
“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. “We designed the SOARA study to build prospective evidence for our test as we continue working toward making earlier ovarian cancer detection available to more women.”