Safety in Ovarian Cancer for Average-Risk Women - Analysis

This is a prospective, decentralized clinical study of the Evident Ovarian Cancer Screening Test in average-risk postmenopausal women aged 50 years and older. Between 1,000 and up to 1,750 participants will be enrolled. The study is intended to characterize the safety profile of the screening strategy, estimate test specificity, and evaluate the burden of downstream diagnostic procedures associated with positive screening results. Eligible participants will complete informed consent procedures and undergo blood collection through a mobile phlebotomy service. Blood specimens will be analyzed using the Evident Ovarian Cancer Screening Test. Participants with negative screening results will not be required to undergo any further study procedures. Participants with positive screening results will be required to undergo transvaginal ultrasound (TVUS) and may elect to undergo additional Evident testing during follow-up. Clinical management decisions will remain under the direction of the participant's treating healthcare provider. Clinical outcomes will be assessed through participant surveys, medical record review when available, and review of relevant imaging and diagnostic findings. Outcomes of interest include adverse events associated with the screening pathway, invasive diagnostic procedures, ovarian cancer diagnoses, and participant-reported psychological burden associated with positive screening results. The primary objectives of the study are to evaluate the safety of the screening strategy, estimate the specificity of the Evident Ovarian Cancer Screening Test, and characterize the downstream procedural burden associated with positive test results in the intended-use population.