Mercy BioAnalytics Receives FDA Approval for Ovarian Cancer Screening Test

WALTHAM, Mass., Sept. 21, 2026 /CourierPR/ -- Mercy BioAnalytics, a company at the forefront of blood-based early cancer detection, has received a significant regulatory milestone. 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. This approval paves the way for the initiation of the SOARA (Safety in Ovarian Cancer for Average-Risk Women, Analysis) Clinical Validation Study, a prospective clinical trial designed to assess the safety of the test in average-risk women.

The SOARA study is a crucial step in Mercy BioAnalytics' ongoing efforts to develop a reliable screening tool for ovarian cancer. Ovarian cancer remains one of the most lethal gynecological cancers, with many cases diagnosed at advanced stages. The lack of an FDA-approved screening test has been a significant challenge in early detection and treatment. Mercy's Evident Ovarian Cancer Screening Test, powered by the company's patented Mercy Halo™ liquid biopsy platform, aims to change this by utilizing biomarker colocalization to identify cancer-associated signatures in blood-based extracellular vesicles and particles.

The SOARA study will evaluate the safety of the Evident™ Ovarian Cancer Screening Test in average-risk women. This prospective clinical validation is expected to provide the necessary data to support the company's ongoing clinical and regulatory program for the test. The approval of the IDE application by the FDA is a critical step, but it does not constitute FDA approval or clearance of the Evident Ovarian Cancer Screening Test. The company must still secure Institutional Review Board (IRB) approval before the study can commence.

Mercy BioAnalytics, founded on the mission to relieve suffering and save lives through early cancer detection, has set its initial focus on ovarian and lung cancers. The Evident Ovarian Cancer Screening Test is part of the company's broader strategy to develop innovative solutions for early cancer detection, potentially improving patient outcomes and reducing the burden of these diseases.

The approval of the IDE application for the Evident™ Ovarian Cancer Screening Test marks a significant step forward in Mercy BioAnalytics' mission to advance early cancer detection. The company's efforts in this area could have a profound impact on the lives of women at risk of ovarian cancer, potentially leading to earlier diagnoses and more effective treatments.