MIRXES-B (02629) has announced the completion of patient enrollment for its CADENCE CRC study. CADENCE, which stands for CAncer Detected Early caN be CurEd, is a large-scale prospective clinical study designed to validate the effectiveness of the company's blood test for colorectal cancer screening in average-risk and high-risk adult populations. The study has enrolled over 6,000 participants across Southeast Asia, making it the first and largest registry study in the region to evaluate a blood-based screening test for colorectal cancer. The participant pool includes diverse ethnic backgrounds such as Chinese, Malay, and Indian, reflecting the real-world demographics of Southeast Asia and strengthening the general applicability of the study's findings.

CADENCE CRC is designed as a prospective validation study to support regulatory approval and clinical adoption of the company's blood-based colorectal cancer screening test. Participants underwent a colonoscopy, the standard reference procedure, to enable a rigorous assessment of clinical performance. Recruitment for the study began in 2023, with the target of enrolling 6,000 participants achieved in early 2026. The completion of enrollment marks a key milestone, and the study will now proceed to the later stages of laboratory analysis and data evaluation. The company expects to announce the primary study results in 2026, following the completion of data analysis and follow-up.

The blood test being evaluated in CADENCE CRC is powered by the company's proprietary miRNA-centric multi-omics platform. This platform integrates (i) tumor-originated signals, (ii) non-tumor host response signals, and (iii) AI-driven machine learning algorithms. This unique miRNA-enabled approach allows for more accurate detection of early-stage, potentially curable colorectal cancer through a simple, non-invasive blood draw, thereby overcoming long-standing barriers to screening acceptance associated with stool tests and colonoscopies. The CADENCE CRC study builds on prior development research, which demonstrated (i) a sensitivity of over 80% for detecting early-stage colorectal cancer and (ii) a specificity of approximately 90%. By prospectively validating these findings in a large Southeast Asian cohort, the study aims to confirm the test's performance in a real-world screening population.

Following the completion of enrollment, the company will proceed with (i) final sample processing and laboratory analysis, (ii) database lock and statistical validation, (iii) preparation for the release of topline data, (iv) communications with regulatory bodies for market access, and (v) subject to successful study outcomes and compliance with applicable regulations, the planned commercial launch of its colorectal cancer blood test as a Laboratory Developed Test (LDT) in Singapore and selected Southeast Asian markets by mid-2026. Concurrently, the company will seek regulatory approval for the test as an in-vitro diagnostic device. The proposed LDT launch will leverage the company's existing laboratory infrastructure and clinical network in Southeast Asia, enabling early market access while continuing to pursue broader regulatory approvals and reimbursement pathways.

The company believes that introducing a clinically validated, convenient blood-based screening option has the potential to increase screening participation rates, improve early detection outcomes, and reduce colorectal cancer mortality in Asia. Colorectal cancer remains a leading cause of cancer-related death in Asia, yet screening coverage in many markets remains suboptimal. In Southeast Asia alone, an estimated 140 to 170 million adults aged 45 to 74 are within the recommended age range for colorectal cancer screening, with the eligible population across Asia exceeding 1.2 billion. Despite this large at-risk population, screening participation rates in many markets are below desired levels. Even a modest increase in coverage represents a significant healthcare opportunity; the addressable market for screening tests in Southeast Asia alone is estimated to be worth billions of dollars annually, depending on the screening method, interval, and pricing. The company believes that a convenient and clinically validated blood-based screening solution can help unlock the potential of this large, underserved population and expand early detection coverage in the region.

The completion of enrollment for CADENCE CRC represents a significant step forward in the company's mission to advance early detection for Asia's most common and lethal cancers, following the successful completion of clinical trials and regulatory approvals in multiple markets for GASTROClear. As the first and largest registry study for a blood-based colorectal cancer screening test in Southeast Asia, CADENCE CRC exemplifies the company's commitment to generating rigorous clinical evidence.