Mercy BioAnalytics Receives FDA Approval for Pivotal Ovarian Cancer Screening Study
Mercy BioAnalytics has received FDA approval to initiate a prospective pivotal study for its Evident™ ovarian cancer screening test. Institutional Review Boards have also approved the study.
WALTHAM, Mass. – Mercy BioAnalytics has received approval from the U.S. Food and Drug Administration (FDA) to begin a pivotal prospective study of its Evident™ ovarian cancer screening test. Institutional Review Board (IRB) approval has also been secured, clearing the way for the "Safety in Ovarian Cancer for Average-Risk Women – Analysis" (SOARA) Clinical Validation Study.
This pivotal study aims to validate the safety and efficacy of the Evident™ test in women at average risk for ovarian cancer. Ovarian cancer is among the deadliest cancers for women, and early detection is critical for improving outcomes. Mercy BioAnalytics' testing method offers a potential new approach to identifying the disease at an earlier stage.
The FDA's Investigational Device Exemption (IDE) allows the company to gather clinical data on the device in the United States for research purposes. The SOARA study will enroll participants from multiple healthcare sites and is expected to provide valuable insights into the Evident™ test's performance in a real-world clinical setting.
According to Mercy BioAnalytics, the Evident™ test analyzes RNA biomarkers from a blood sample, which may help identify early signs of ovarian cancer. The company anticipates that the study results will support the test's future approval and commercialization, potentially improving screening capabilities for women.