Mercy BioAnalytics Receives FDA Approval to Initiate Prospective Pivotal Study of Evident™Ovarian Cancer Screening Test
IDE approval enables initiation of the pivotal Safety in Ovarian Cancer for Average-Risk Women – Analysis ("SOARA") Clinical Validation Study following Institutional Review Board approval
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."
Ovarian cancer remains among the most lethal gynecologic cancers and is frequently diagnosed at an advanced stage. There is currently no FDA-approved screening test for ovarian cancer. FDA previously granted Breakthrough Device Designation to Mercy's ovarian cancer test.
The Evident Ovarian Cancer Screening Test is powered by Mercy's patented Mercy Halo™ liquid biopsy platform, which uses biomarker colocalization to interrogate highly abundant, blood-based extracellular vesicles and particles that carry cancer-associated signatures from their cells of origin.
Approval of the IDE application permits Mercy to conduct the specified clinical investigation. It does not constitute FDA approval or clearance of the Evident Ovarian Cancer Screening Test.
About Mercy BioAnalytics
Mercy BioAnalytics, Inc. is on a mission to relieve suffering and save lives through the early detection of cancer. Early-stage cancer is difficult to detect, but when found, is more often amenable to curative therapy. Mercy's patented Mercy Halo™ liquid biopsy platform utilizes biomarker colocalization to interrogate highly abundant, blood-based extracellular vesicles and particles that carry unique cancer signatures from their parent cells. Mercy's initial focus is the early detection of ovarian and lung cancers.
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