Evident ovarian cancer screening test: What SOARA will measure

The FDA approved an investigational device exemption (IDE) application for the Evident Ovarian Cancer Screening Test, a blood-based test intended to screen average-risk postmenopausal women for ovarian cancer. No FDA-approved ovarian cancer screening test existed, and the agency had previously granted the test Breakthrough Device Designation.¹

According to Dawn Mattoon, PhD, CEO of Mercy BioAnalytics, Inc, the IDE approval allowed Mercy BioAnalytics, following institutional review board approval of the protocol, to start enrolling and complete a prospective interventional trial evaluating the safety of the test in its intended use population. In reviewing the application, the FDA needed to be convinced that the trial, called SOARA, was safe and appropriately designed to achieve its end point. The approval did not constitute FDA approval of the test itself, a step that still lay ahead, Mattoon said.

Safety was the central question because of how ovarian cancer is diagnosed.

“In the setting of ovarian cancer, the only way to achieve a definitive diagnosis is through a surgical procedure. It isn’t the kind of thing that we can diagnose through imaging or other noninvasive modalities,” Mattoon said. A population screening test therefore had to demonstrate that it would not refer an inappropriate number of women for invasive diagnostic procedures. False-positive results leading to unnecessary surgical interventions have been identified as a key harm of ovarian cancer screening in asymptomatic women.²

The test had been in development for approximately 8 years. Clinical evidence generated to date came from blinded evaluation of banked samples from cohorts enrolled in previously conducted prospective randomized controlled trials. Those analyses produced robust sensitivity and specificity data, but they could not establish the test’s safety profile. That question could be examined only through prospective use of the test in a contemporary US health care setting, according to Mattoon.

The test had a false-positive rate of 2%, corresponding to a specificity of 98%.

“It’s very important to us, and it’s very important to the FDA that we understand for those women who have a false positive result, how is their care managed?” Mattoon said.

Under the SOARA protocol, any woman with a positive result was to be referred for transvaginal ultrasound. Additional testing, such as human epididymis protein 4 or cancer antigen 125, could be ordered at the discretion of the provider. The study was designed to follow how those women were managed, including the percentage who went on to undergo an invasive diagnostic procedure.

Specifically, SOARA was designed to evaluate the number of invasive procedures performed per number of women screened. Mercy BioAnalytics had established parameters it deemed acceptable for that measure, and the study was intended to provide data showing that the test met those safety parameters, Mattoon said.

References

1. Mercy BioAnalytics receives FDA approval to initiate prospective pivotal study of Evident ovarian cancer screening test. Press release. Published September 21, 2026. Accessed October 8, 2026. https://mercybio.com/2026/09/mercy-bioanalytics-receives-fda-approval-to-initiate-prospective-pivotal-study-of-evidentovarian-cancer-screening-test/
2. US Preventive Services Task Force; Grossman DC, Curry SJ, Owens DK, et al. Screening for ovarian cancer: US Preventive Services Task Force recommendation statement. JAMA. 2018;319(6):588-594. doi:10.1001/jama.2017.21926