FDA Approves Mercy BioAnalytics IDE for Pivotal SOARA Study of Evident Ovarian Cancer Screening Test
核心洞察
The FDA has approved Mercy BioAnalytics (搜索)' Investigational Device Exemption application for the Evident Ovarian Cancer Screening Test (搜索), allowing use of the test in a pivotal clinical study.
The prospective SOARA Clinical Validation Study will evaluate the safety of the blood-based test for ovarian cancer (搜索) screening in average-risk women, pending Institutional Review Board approval.
Ovarian cancer (搜索) is among the most lethal gynecologic cancers and is frequently diagnosed at an advanced stage, with no FDA-approved screening test currently available.
Mercy BioAnalytics (搜索) has received FDA approval of its Investigational Device Exemption (IDE) application for the Evident Ovarian Cancer Screening Test (搜索), clearing the company to use the test in its pivotal SOARA Clinical Validation Study. The Waltham, Massachusetts-based company announced the approval on Sept. 21, 2026.
The SOARA study, short for Safety in Ovarian Cancer (搜索) for Average-Risk Women – Analysis, is a prospective clinical study designed to evaluate the safety of the test when used for ovarian cancer screening in average-risk women. Initiation of the study follows Institutional Review Board (IRB) approval. Mercy said the study is expected to support its ongoing clinical and regulatory program for the Evident 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 (搜索). "We designed the SOARA study to build prospective evidence for our test as we continue working toward making earlier ovarian cancer (搜索) detection available to more women."
Regulatory Status and Unmet Need
Ovarian cancer (搜索) 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. The FDA previously granted Breakthrough Device Designation to Mercy's ovarian cancer test.
Mercy noted that approval of the IDE application permits the company to conduct the specified clinical investigation and does not constitute FDA approval or clearance of the Evident Ovarian Cancer Screening Test (搜索).
Platform Technology
The Evident Ovarian Cancer Screening Test (搜索) is powered by Mercy's patented Mercy Halo (搜索) liquid biopsy platform. The platform uses biomarker colocalization to interrogate highly abundant, blood-based extracellular vesicles and particles that carry cancer-associated signatures from their cells of origin.
According to the company, early-stage cancer is difficult to detect but, when found, is more often amenable to curative therapy. Mercy's initial focus is the early detection of ovarian and lung cancers.