557P - Three-year update of real-world evaluation of ColonAiQ for colorectal cancer screening in asymptomatic individuals

Background

The three-year PreC cohort study aimed to assess the efficiency of ColonAiQ®, a blood-based assay targeting circulating tumor DNA methylation, in stratifying the risk for colorectal cancer (CRC) and advanced adenoma (AA).

Methods

From Jan 2021 to Dec 2023, 219,456 participants aged 40 to 80, residing in the local community of Yangzhou city, were recruited. The ColonAiQ® test, long with a risk questionnaire, served as the primary screening tool for all participants. Those individuals with a positive primary result were recommended to undergo colonoscopy. The study evaluated the numbers of positive ColonAiQ® test, colonoscopy compliance rate, and positive predictive values for AA and/or CRC.

Results

Among 219,456 participants, 13,469 (6.14%) tested positive with the ColonAiQ® assay. Of these, 5,651 (41.96%) underwent colonoscopy, leading to pathological confirmation. Overall, 3,191 (56.47%) participants had confirmed colonoscopy findings, including 117 (2.07%) cases of CRC, 806 (14.26%) cases of AA, 1086 (19.22%) cases of non-advanced adenoma, 824 (14.58%) cases of small polyps, and 358 (6.34%) cases of non-neoplastic colorectal disorders. Notably, the diagnosis rate of early colorectal neoplasm reached 89.71%. Positive prediction values were estimated at 2.07% for CRC and 33.48% for adenoma (14.26% for AA), respectively, based on participants with colonoscopy outcomes.

Conclusions

The three-year real-world study confirms the utility of ColonAiQ® test in stratifying the risks of CRC and adenoma among the average-risk population. It significantly improved the compliance rate of colonoscopy, achieving 41.96% compared to the average rate of 17.25% in Cancer Screening Program in Urban China. ColonAiQ® test demonstrates its potential to identify asymptomatic patients with neoplasm who may benefit from early treatments, such as endoscopic resection or surgery excision. These findings from the ongoing PreC study underscore the cost-effectiveness of a two-step screening strategy in community populations, which may influence future cancer screening policy.

Clinical trial identification

ClinicalTrials.gov Identifier: NCT05336539.

Editorial acknowledgement

Legal entity responsible for the study

National Center for Chronic and Non-Communicable Disease Control and Prevention, Chinese Center for Disease Control and Prevention.

Funding

Hanjiang district commission of Health, Yangzhou, China.

Disclosure

H. Liu: Financial Interests, Institutional, Full or part-time Employment: Singlera Genomics (China) LTD. Y. Li: Financial Interests, Institutional, Full or part-time Employment: Singlera Genomics (China) LTD. Q. Yuan: Financial Interests, Institutional, Full or part-time Employment: Singlera Genomics (China) LTD. C. Wang: Financial Interests, Institutional, Full or part-time Employment: Singlera Genomics (China) LTD. H. Jia: Financial Interests, Institutional, Full or part-time Employment: Singlera Genomics (China) LTD. B. li: Financial Interests, Institutional, Full or part-time Employment: Singlera Genomics (China) LTD. Y. Zhang: Financial Interests, Institutional, Full or part-time Employment: Singlera Genomics (China) LTD. R. Liu: Financial Interests, Institutional, Full or part-time Employment: Singlera Genomics (China) LTD. All other authors have declared no conflicts of interest.