Mirxes Holding Company Limited (together with its subsidiaries, the Group) has completed enrolment in the CADENCE CRC study, marking a key milestone. The prospective clinical trial enrolled more than 6,000 participants across Southeast Asia, including people of Chinese, Malay, and Indian ethnicities. It aims to validate a blood-based test designed to detect colorectal cancer among average- and high-risk adults.
The CADENCE CRC study applies a miRNA-centric multi-omics platform, integrating tumor-originated signals, non-tumor host-response signals, and AI-enabled machine learning. The blood test is intended to offer a convenient, non-invasive alternative to stool-based testing or colonoscopy. Previous development studies have indicated sensitivity exceeding 80% in identifying early-stage colorectal cancer and about 90% specificity.
With enrolment complete, the study transitions to final laboratory analysis and data evaluation, with topline results expected to be released following data analysis in 2026. Subject to successful completion and regulatory clearance, the Group plans to introduce the blood test as a Laboratory Developed Test in Singapore and selected Southeast Asia markets by mid-2026, while pursuing broader regulatory approvals in parallel.
Colorectal cancer remains a leading cause of cancer-related mortality in Asia. Across Southeast Asia, an estimated 140.00 million to 170.00 million adults fall within recommended screening age groups, while across Asia the eligible population is about 1.20 billion. The Group believes a validated blood-based screening solution could significantly boost early detection rates and help address the unmet need for colorectal cancer screening in the region.