Mercy BioAnalytics Receives FDA Approval for Pivotal Ovarian Cancer Screening Study
Mercy BioAnalytics, Inc. has announced that the U.S. Food and Drug Administration (FDA) has approved its Investigational Device Exemption (IDE) application for the Evident™ Ovarian Cancer Screening Test. This approval permits Mercy BioAnalytics to initiate its pivotal SOARA Clinical Validation Study. The study is a prospective clinical trial designed to assess the safety of the Evident test when used for ovarian cancer screening in women at average risk, contingent upon Institutional Review Board (IRB) approval. The company aims for this study to support its ongoing clinical and regulatory efforts for the Evident Ovarian Cancer Screening Test. The Evident test utilizes Mercy's patented Mercy Halo™ liquid biopsy platform, which identifies cancer-associated signatures from extracellular vesicles and particles in blood. This FDA approval marks a significant step in advancing the test through the regulatory review process, as stated by Dawn Mattoon, Ph.D., Chief Executive Officer of Mercy BioAnalytics.
