FDA approves IDE for pivotal study of Evident ovarian cancer screening test

According to a new announcement from Mercy BioAnalytics, the FDA has approved the company's investigational device exemption (IDE) application for the Evident Ovarian Cancer Screening Test (Mercy BioAnalytics).¹ The approval allows the company to use the blood-based test in its pivotal SOARA Clinical Validation Study once institutional review board (IRB) approval is secured.¹ SOARA is a prospective study designed to evaluate the safety of the Evident ovarian cancer screening test in average-risk women.¹

No FDA-approved screening test for ovarian cancer currently exists, leaving ob-gyns without an approved screening option for average-risk patients.¹ The IDE moves a candidate blood-based screening assay into prospective pivotal evaluation.¹

SOARA stands for Safety in Ovarian Cancer for Average-Risk Women – Analysis.¹ The company described the study as prospective and designed to assess the safety of the Evident test when used for ovarian cancer screening in the average-risk population.¹ Enrollment targets, participating sites, and an NCT number were not disclosed in the announcement.

Primary and secondary end points, including performance measures such as sensitivity, specificity, and positive predictive value, were also not reported. Initiation of SOARA remains contingent on IRB approval.¹ The announcement did not provide a projected start date or a timeline for data readout.

How does the Mercy Halo liquid biopsy platform power the Evident test?

The Evident test runs on the company's patented Mercy Halo liquid biopsy platform.¹ The platform relies on biomarker colocalization to interrogate extracellular vesicles and particles, which circulate in high abundance in blood and carry cancer-associated signatures from their cells of origin.¹

The FDA previously granted Breakthrough Device Designation to the company's ovarian cancer test.¹ The company expects SOARA to support its ongoing clinical and regulatory program for the Evident test.¹ Mercy's initial focus across its pipeline is the early detection of ovarian and lung cancers.¹

According to the announcement, IDE approval permits the company to conduct the specified clinical investigation only.¹ It does not constitute FDA approval or clearance of the Evident Ovarian Cancer Screening Test, which remains investigational.¹ Prospective safety and performance data from SOARA have not yet been generated.

Dawn Mattoon, PhD, chief executive officer of Mercy BioAnalytics, called the IDE approval "an important milestone" in advancing the test through regulatory review.¹ "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,” Mattoon added.¹

For ob-gyns, the announcement does not change current screening practice, as the Evident test remains investigational and unavailable outside the study.¹ Patients asking about blood-based ovarian cancer screening can be told the test is entering prospective pivotal evaluation and has not received FDA approval or clearance.¹ Eligibility criteria and participating sites have not yet been released.

Reference

1. Mercy BioAnalytics receives FDA approval to initiate prospective pivotal study of Evident ovarian cancer screening test. News release. Mercy BioAnalytics; September 21, 2026. Accessed September 23, 2026. https://www.prnewswire.com/news-releases/mercy-bioanalytics-receives-fda-approval-to-initiate-prospective-pivotal-study-of-evidentovarian-cancer-screening-test-302885020.html