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

Sep 22, 2026

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Earlier detection of colorectal cancer (CRC) can improve survival, and a simple blood test could increase screening uptake. This study evaluates the multi-target blood protein (MTBP; ColoSTAT®) test and algorithm, which uses five CRC protein biomarkers plus patient sex and age to generate a CRC likelihood score. The study compares MTBP performance against colonoscopy as the gold standard, assessing sensitivity and specificity in enrolled cohorts.

LanguageEnglish

CategoryResearch & Report

FormatPDF

Pages11

Reading Time28 min

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Abstract

Purpose

Methods

Results

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Introduction

Journal of Gastrointestinal Cancer (2026) 57:19 [https://doi.org/10.1007/s12029-025-01373-y](https://doi.org/10.1007/s12029-025-01373-y) RESEARCH A Prospective, Cross-Sectional, Multicenter Study Evaluating a Multi-Target Blood Protein in Vitro Diagnostic Test for Colorectal Cancer Emily Y. He1 · Guy A. van Hazel2 · Andrew M. Sloss3 · Stephen Pianko4 · Gregor J. Brown5 · Philip R. Clingan6 · Rajvinder Singh7 · Ann C. Solterbeck8 · Robert Traficante8 · Louise Formby-Miller9 · Trevor Lockett9 · Finlay Macrae10 Accepted: 7 December 2025 © The Author(s) 2026 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 scheduled for colonoscopy (Cohort 2) . Due to COVID-19 pandemic-related recruitment delays, Cohort 1 was supplemented with bio-banked blood samples (BBS) from patients with clinically confirmed CRC. Performance goals for sensitivity and specificity of the MTBP test compared to colonoscopy were ≥ 73%(lower 95% confidence limit [LCL] > 60%) and ≥ 90%(LCL> 80%), respectively. Results Cohort 1 included 29 patients, Cohort 2 enrolled 768 patients and 192 BBS were included. Median age when providing samples was 64 years (range, 40–85 years); 53.4% were female. Definitive MTBP test results were obtained from 657 samples. 112 and 389 samples met the criteria for inclusion in the primary sensitivity and specificity analyses, respectively. The sensitivity of ColoSTAT® for detection of all-stage CRC compared to colonoscopy was 81 .3%(95%CL 73 .0%-87 .4%) and the specificity, 91.0%(95%CL 87.7%-93.5%) . Conclusions The MTBP test met pre-specified primary performance endpoints and warrants further evaluation in clinical populations at elevated risk ofCRC. Keywords Biomarkers · Early detection of cancer · Colonoscopy · Colorectal cancer · Mass screening Introduction Globally, most colorectal cancer (CRC) screening guidelines recommend screening average-risk individuals aged 50–75 years every 10 years with colonoscopy, every 5 years with flexible sigmoidoscopy, or every 1 or 2 years with a fecal occult blood test (FOBT), with a positive FOBT followed up with colonoscopy [1] . Colonoscopy is considered the ‘gold standard’ as it can examine the whole colon and allows removal of pre-cancerous polyps during examination [1] . However, colonoscopy is also invasive, associated with the risk of complications such as bowel perforation and bleeding, requires bowel preparation, is resource intensive Extended author information available on the last page of the article and is expensive [2]. Participation in colonoscopy screening is often poor [3] . Regular screening using FOBT can reduce CRC-associated morbidity and mortality. Immunochemical fecal occult blood tests (iFOBT or more commonly Fecal Immunochemical Test (FIT) have shown improved sensitivity and specificity compared with guaiac occult blood detection [2, 4, 5] . However, the effectiveness of screening depends on participation, which varies between programs and modes of screening. Participation rates for FIT range from 68.2% in the Netherlands to 16% in provincial programs in Canada [6]. A worldwide systematic review ofCRC screening studies found participation rates after the first invitation to be only 42%(95% confidence interval [CI] 42.2%-42.5%) for guaiac FOBT and 47%(95%CI 46.5%-46.6%) for FIT [1] . 1 3 Multiple p

FAQs

What is being evaluated in this study?

The study evaluates the multi-target blood protein (MTBP; ColoSTAT®) in vitro diagnostic test for detecting colorectal cancer, using an algorithm based on five protein biomarkers plus patient sex and age.

What is the gold standard comparator?

Colonoscopy is used as the gold standard, serving as the reference for comparing MTBP test performance.

How were participants organized for analysis?

Two cohorts were enrolled: participants recently colonoscopically diagnosed with CRC progressing to surgery or neoadjuvant treatment, and participants with no CRC history scheduled for colonoscopy; additional bio-banked blood samples supplemented cohort 1.

Sep 22, 2026

Upload by Patrick