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Validation of an extracellular vesicle-based screening assay for detecting early-stage ovarian cancer

Principal Investigator
Name
Toumy Guettouche
Degrees
Ph.D.
Institution
Mercy BioAnalytics, Inc.
Position Title
CSO
Email
About this CDAS Project
Study
PLCO (Learn more about this study)
Project ID
2024-0114
Initial CDAS Request Approval
Feb 3, 2025
Title
Validation of an extracellular vesicle-based screening assay for detecting early-stage ovarian cancer
Summary
This study will be a retrospective analysis of samples from a prospective cohort study in which all samples will be from asymptomatic, postmenopausal women. Samples will be blinded and tested on the Mercy Halo Ovarian Cancer Screening test (Mercy Halo test) in order to determine if ovarian cancer is detected. Results of the Mercy Halo test will be compared to clinical diagnosis, including surgery and biopsy results.
Aims

The primary aims of this study include:
• Sensitivity of the Mercy Halo test in detecting invasive epithelial ovarian cancer (iEOC), relative to clinical diagnosis
• Specificity of the Mercy Halo test
• Prevalence-adjusted PPV and NPV
The secondary aims of this study include:
• Sensitivity of the Mercy Halo test in detecting high-grade serous ovarian cancer (HGSOC), relative to clinical diagnosis
• Sensitivity in detecting other, non-iEOC ovarian cancer histologies
• Sensitivity delineated by stage of cancer
• Sensitivity relative to time of sample collection prior to clinical diagnosis
• Performance (sensitivity/specificity) comparison to CA125

Collaborators

Toumy Guettouche (Mercy BioAnalytics, Inc.)
Michael Smith (Mercy BioAnalytics, Inc.)
Daniel Salem (Mercy BioAnalytics, Inc.)
Brendan Manning (Mercy BioAnalytics, Inc.)
Troy Hawkins (Mercy BioAnalytics, Inc.)