584P - Two-year update of the prospective evaluation of ColonAiQ (PreC) study

Background

PreC study supported ColonAiQ® (a blood-based assay targeting circulating tumor DNA methylation) as a robust noninvasive option for colorectal cancer (CRC) and advanced adenoma (AA) screening to efficiently stratify individuals with a higher risk based on the first year’s real-world data reported in 2022 World Congress on Gastrointestinal Cancer (LBA SO-23). Here, the update CRC screening outcome was reported.

Methods

105,285 participants living in the local community, aging from 40 to 80, were recruited from Jan 2021 to Dec 2022. ColonAiQ® test was used as the primary screening method for all participants and a follow-up colonoscopy was recommended after a positive primary test. Numbers of positive ColonAiQ® test, colonoscopy compliance rate and positive predictive values (PPV) for AA and/or CRC were determined.

Results

Overall, a total of 6,759 participants (6.42%) were tested positive via ColonAiQ® test. In the positive test population, 3,282 (48.56%) participants performed colonoscopy with pathological confirmation. Overall, there were 1,773 (54.02%) participants confirmed with colonoscopy findings, including 63 (1.92%) CRC, 441 (13.44%) AA, 754 (22.97%) non-advanced adenoma, 327 (9.96%) polyps, and 188 (5.73%) non-neoplastic GI disorders. Particularly, early colorectal neoplasm diagnosis rate reached 90.28%. Therefore, The predictive value (PPV) was 1.92% for CRC and 36.41% for adenoma (13.44% for AA).

Conclusions

The 2-year real world study confirms the initial findings that population compliance rate of colonoscopy is obviously higher than the average rate in Cancer Screening Program in Urban China (48.56% VS 17.25%). ColonAiQ® test could help to identify the asymptomatic patients with neoplasm who need endoscopic resection or surgery excision. These results warrant the cost-effectiveness of the two-step screening pattern in community populations from the ongoing PreC study.

Clinical trial identification

NCT05336539.

Editorial acknowledgement

Legal entity responsible for the study

The authors.

Funding

Singlera Genomics Inc.

Disclosure

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