Mercy BioAnalytics, Inc.
This study is designed to evaluate the safety, specificity, and downstream diagnostic burden of the Evident™ Ovarian Cancer Screening Test in average-risk postmenopausal women. Participants will provide a blood sample for screening and will be followed for approximately 12 months to assess test safety, specificity, downstream diagnostic procedures, and ovarian cancer outcomes.
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 u…
Inclusion Criteria: * Postmenopausal women with one or both ovaries * Age 50 years or more * No personal history of ovarian cancer * No hereditary cancer syndrome of genetic risk factors associated with ovarian cancer * Willingness to allow medical record review * Willingness to have blood drawn * Ability to provide informed consent Exclusion Criteria: * Removal of both ovaries for any reason * Known genetic risk factors associated with ovarian cancer or hereditary cancer syndrome * Pregnant or breastfeeding * Currently under clinical surveillance due to a known or suspected elevated risk o…
A blood sample will be collected and analyzed using an investigational blood-based ovarian cancer screening test. Participants with positive screening results will be advised to undergo follow-up transvaginal ultrasound (TVUS) and may elect repeat blood-based testing. Additional clinical evaluation is determined by their healthcare provider.
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