LBA SO-23 Real-world evaluation of clinical utility of ColonAiQ, a blood-based assay for colorectal cancer (CRC) early detection

Background: CRC is the third most common diagnosed cancer in recent years, and the second leading cause of cancer death globally, and it's also the second most common cancer and the fifth leading cause of cancer death in China. We have developed a multi-locus blood-based assay, ColonAiQ, targeting circulating tumor DNA methylation. It has demonstrated the ability of non-invasive early detection for CRC and advanced adenoma (AA). The prospective evaluation of ColonAiQ (PreC) study is an ongoing real-world cohort study organized in Yangzhou, China, which aims to evaluate whether the ColonAiQ test can improve patient compliance and detect CRC and AA in asymptomatic population. Methods: From Jan. to Dec. of 2021, 39,880 participants at average-risk of CRC, aging from 40 to 80, were voluntarily enrolled in PreC study. ColonAiQ tests were conducted for all participants and a follow-up colonoscopy was recommended for the test-positive individual. We are collecting and analyzing the real-world data to assess clinical utility of ColonAiQ assay. Results: Among 39,880 participants, 2,823 participants (7.08%) tested positive via the ColonAiQ test. Collectively, 53.84% (1,520) of positive ones were willing to undergo a screening colonoscopy followed with pathological confirmation. Overall, there are 811 (53.36%) participants confirmed with colonoscopy findings, including 26 (3.21%) CRC, 208 (25.65%) AA, 431(53.14%) non-advanced adenoma, 74 (9.12%) polyps, and 72 (8.88%) non-neoplastic GI disorders. The predictive value (PPV) is 1.71% for CRC and 42.04% for adenoma (13.68% for AA). Conclusions: From real-world data, the patient compliance of colonoscopy in PreC study participants is significantly increased from 17.25% to 53.84%. ColonAiQ test has detected 665 asymptomatic patients with neoplasm who need endoscopic resection or surgery excision. PreC study supports ColonAiQ as a robust noninvasive option for CRC/AA screening to efficiently stratify individuals with a higher risk in more cost-effective manner. Legal entity responsible for the study: The authors. Funding: Singlera Genomics Inc, Shanghai, China. Disclosures: Y. Ding: Full / Part-time employment: Singlera Genomics(Shanghai) Ltd. J. Liu: Full / Part-time employment: Singlera Genomics (Shanghai) Ltd. R. Liu: Shareholder / Stockholder / Stock options: Singlera Genomics (Shanghai) Ltd.; Full / Part-time employment: Singlera Genomics (Shanghai) Ltd. Y. Li: Full / Part-time employment: Singlera Genomics (Shanghai) Ltd. F. Li: Full / Part-time employment: Singlera Genomics (Shanghai) Ltd. C. Wang: Full / Part-time employment: Singlera Genomics (Shanghai) Ltd. H. Jia: Full / Part-time employment: Singlera Genomics (Shanghai) Ltd. W. Pan: Full / Part-time employment: Singlera Genomics (Shanghai) Ltd. H. Yang: Full / Part-time employment: Singlera Genomics (Shanghai) Ltd. H. Luo: Full / Part-time employment: Singlera Genomics (Shanghai) Ltd. Y. Li: Full / Part-time employment: Singlera Genomics (Shanghai) Ltd. All other authors have declared no conflicts of interest.