A Prospective, Cross-Sectional, Multicenter Study Evaluating a Multi-Target Blood Protein in Vitro Diagnostic Test...

Area of Science:

• Oncology
• Biomarker Discovery
• Cancer Diagnostics

Background:

• Early detection of colorectal cancer (CRC) significantly improves patient survival rates.
• Improving screening participation is crucial for effective CRC management.
• A simple blood test could enhance screening accessibility and adherence.

Purpose of the Study:

• To evaluate the performance of a multi-target blood protein (MTBP) test, ColoSTAT®, in detecting colorectal cancer (CRC).
• To compare the diagnostic accuracy of the MTBP test against colonoscopy, the established gold standard for CRC diagnosis.

Main Methods:

• A cross-sectional, multicenter study involving two cohorts: CRC patients and individuals scheduled for colonoscopy.
• Inclusion of bio-banked samples from CRC patients to supplement the primary cohort.
• Performance evaluation based on pre-defined sensitivity (≥73%) and specificity (≥90%) goals.

Main Results:

• The study included 29 patients in Cohort 1, 768 in Cohort 2, and 192 bio-banked samples.
• ColoSTAT® demonstrated a sensitivity of 81.3% (95% CL 73.0%-87.4%) for detecting all stages of CRC.
• The specificity of ColoSTAT® was 91.0% (95% CL 87.7%-93.5%) compared to colonoscopy.

Conclusions:

• The MTBP test (ColoSTAT®) successfully met its primary performance objectives for CRC detection.
• The test warrants further investigation in clinical settings, particularly for high-risk populations.
• This blood test shows potential as a non-invasive tool to aid in CRC screening.