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IDDF2022-ABS-0108 Clinical validation of a faecal bacterial signature test for colorectal cancer screening
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IDDF2022-ABS-0108 Clinical validation of a faecal bacterial signature test for colorectal cancer screening
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Journal Article
IDDF2022-ABS-0108 Clinical validation of a faecal bacterial signature test for colorectal cancer screening
2022
Overview
BackgroundThe faecal immunochemical test (FIT) is the most widely used test for colorectal cancer (CRC) screening. RAIDCRCScreen is a non-invasive test based on faecal biomarkers that complement FIT by increasing its specificity. It was previously clinically evaluated in FIT-positive patients (>20µg haemoglobin/g faeces, ‘FIT20’), in which it reduced the proportion of false-positive (FP) results by 16.3% for CRC and for advanced neoplasia (AN) while maintaining FIT20’s sensitivity for CRC detection.The aim was to demonstrate superiority in specificity and non-inferiority in sensitivity of the RAIDCRCScreen versus FIT20 in a screening cohort undergoing colonoscopy.MethodsA cohort of 2481 subjects aged >55 years from the German CRC screening program was retrospectively included in the DKFZ. They collected a faecal sample prior to colonoscopy to analyse the FIT and the RAID-CRC-Screen test.ResultsRAIDCRCScreen maintained the sensitivity of FIT20 (66.7%) for CRC detection while showing a significantly higher specificity (97.0% vs. 96.1%, p<0.0001). The positive predictive value was higher for RAIDCRCScreen (11.9%) compared with FIT20 alone (9.5%), and the negative predictive value was 99.8% for the two tests. The sensitivity of RAIDCRCScreen in detecting AN was significantly lower compared with FIT20 alone (19.9% vs. 24.8%, p<0.001), whereas the specificity was significantly higher (98.3%) compared with FIT20 alone (97.8%) (p<0.005).In terms of added value over FIT, RAIDCRCScreen reduced the proportion of FIT20 FP by 22.1% while maintaining 100% the proportion of true positives identified by FIT20. For the detection of AN, RAIDCRCScreen decreased the FP rate by 20.4%. The proportion of FIT20 true positives that RAIDCRCScreen still identified was reduced to 80.4%. These results are in line with those obtained in previous studies for both CRC and AN endpoint.ConclusionsOur results elucidate the potential of RAIDCRCScreen to improve the precision of the current CRC screening avoiding unnecessary colonoscopies. The introduction in clinical practice of a three-step CRC screening strategy in which RAIDCRCScreen is performed in FIT-positive individuals can help to rationalize the allocation of resources and alleviate the assistential and economic burden of the healthcare system.
Publisher
BMJ Publishing Group Ltd and British Society of Gastroenterology,BMJ Publishing Group LTD
Subject
