Abstract 6203: Evaluating cost-effectiveness and clinical utility of a blood-based colorectal cancer (CRC) early detection assay, ColonAiQ࣪, through a real-world study in average-risk population (PreC)

Abstract Background: Effective non-invasive colorectal cancer (CRC) screening assays, with high sensitivity and specificity, are desired to increase patient compliance, improve early detection, and reduce CRC mortality. Current stool-based tests suffer with the handling difficulties with specimen, while blood-based tests that rely on single gene methylation have limited sensitivity. We have developed a multi-locus blood-based assay targeting circulating tumor DNA methylation, ColonAiQ, which was demonstrated the ability of early detection for CRC and advanced adenoma (AA) [1]. Study Design: We further organized a real-world cohort aiming for recruiting 120,000 average-risk population to evaluate ColonAiQ’s cost-effectiveness and clinical utility over a 3-year period. This Prospective evaluation of ColonAiQ, PreC study, is organized in Yangzhou city in China being supported by the local government and hospitals. Results: From Jan. 2021 to Aug. 2021, 21,735 apparently healthy volunteers aging from 40 to 80 (median 61.8) were recruited with 10ml blood draw to process with ColonAiQ assay. One thousand six hundred and thirty (7.5%) were tested positive in ColonAiQ, among which 650 were further examined by colonoscopy followed by pathological diagnosis on the biopsy specimen. We successfully identified 330 patients with neoplasm, including 14 (4.3%) asymptomatic CRC, 99 (30%) AA, 184 (43.9%) multi-adenoma or non-advanced adenoma, 33 (10%) polyps, together with 19 patients with non-neoplastic GI disorders. The positive predictive value (PPV) is primarily estimated as 2.2% for CRC and 15.2% for AA (43.5% for adenoma), although these numbers can be largely influenced by the scale of the sample size. Among those 14 identified CRC cases, none of them were tested positive in fecal immunochemical test (FIT), the current screening method locally available. Conclusion: Results from this real-world analysis of ColonAiQ performance, although a preliminary subset, demonstrates the assay robustness, tester compliance, patient adherence to the test result, substantially maximizing its potential benefits for average-risk CRC screening. ColonAiQ significantly increases the detection rate for precancerous adenomas and early-stage CRC when compared to existing molecular screening tests, which could greatly improve preventative care and CRC patient survival. Citation Format: Yanbing Ding, Jun Liu, Yongsheng Li, Cuiping Wang, Huisong Luo, Yang Li, Tingdong Tang, Hui Wang, Wenjun Pan, Huimin Yang, Haipeng Jia, Yunzhi Zhang, Rui Liu. Evaluating cost-effectiveness and clinical utility of a blood-based colorectal cancer (CRC) early detection assay, ColonAiQ࣪, through a real-world study in average-risk population (PreC) [abstract]. In: Proceedings of the American Association for Cancer Research Annual Meeting 2022; 2022 Apr 8-13. Philadelphia (PA): AACR; Cancer Res 2022;82(12_Suppl):Abstract nr 6203.