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

Abstract

Purpose: Earlier detection of colorectal cancer (CRC) can improve survival rates. A simple, effective blood test may help improve screening participation. The multi-target blood protein (MTBP; ColoSTAT®) test and algorithm uses concentrations of five protein biomarkers of CRC and patient’s sex and age to generate a CRC likelihood score. We compared the performance of the MTBP test in detecting CRC to colonoscopy, the ‘gold standard’. Methods: This cross-sectional, multicenter study enrolled participants into two cohorts: participants recently colonoscopically diagnosed with CRC and progressing to surgery or neoadjuvant treatment (Cohort 1), and participants with no CRC history who were sched..