Mirxes Holding Company Limited Announces Completion of Enrolment in Landmark CADENCE CRC Study

Key Highlights and Potential Impact for Investors

Mirxes Holding Company Limited (Stock Code: 2629) has announced a major milestone: the completion of participant enrolment for its pivotal CADENCE (CAncer Detected Early caN be CurEd) CRC study. This large, prospective clinical trial is set to validate Mirxes’ proprietary blood-based screening test for colorectal cancer (CRC) in both average- and high-risk adults across Southeast Asia.

1. Study Overview and Significance

• CADENCE CRC is the first and largest registrational study in Southeast Asia evaluating a blood-based CRC screening test, with over 6,000 participants enrolled.
• The cohort is notable for its diversity, including Chinese, Malay, and Indian ethnicities, closely reflecting the real-world demographic profile of Southeast Asia and strengthening the generalizability of findings.
• The study is designed as a prospective validation to support regulatory and clinical adoption. All participants undergo standard-of-care colonoscopy as the reference method, ensuring rigorous evaluation of the test’s clinical performance.
• Enrolment began in 2023 and achieved its target cohort in early 2026, marking the transition to final laboratory analysis and data evaluation phases.

2. Proprietary Technology and Clinical Potential

• The evaluated test is powered by Mirxes’ miRNA-centric multi-omics platform, integrating:
  • Tumour-originated signals
  • Non-tumour host-response signals
  • AI-enabled machine learning algorithms
• This approach aims to improve early and potentially curable CRC detection via a simple, non-invasive blood draw, directly addressing limitations of stool-based tests and colonoscopy.
• Previous studies have shown sensitivity exceeding 80% and specificity of approximately 90% in early-stage CRC detection. CADENCE CRC is set to validate these findings in a large, real-world population.

3. Next Steps and Commercialisation Plans

• With enrolment complete, Mirxes will advance to:
  1. Final sample processing and laboratory analysis
  2. Database lock and statistical validation
  3. Preparation for topline data announcement
  4. Regulatory and market access engagement
  5. Subject to successful outcomes, initiate commercialisation as a Laboratory Developed Test (LDT) in Singapore and selected Southeast Asia markets by mid-2026, while concurrently seeking full regulatory approval as an In Vitro Diagnostic device
• The LDT launch will leverage Mirxes’ established laboratory and regional clinical networks, enabling early market access and positioning the company for broader regulatory and reimbursement approvals.
• The company believes a convenient, clinically validated blood-based screening option could significantly increase screening uptake, improve early detection, and reduce colorectal cancer mortality across Asia.

4. Market Opportunity and Strategic Importance

• Colorectal cancer is a leading cause of cancer mortality in Asia, with screening rates remaining suboptimal.
• In Southeast Asia alone, there are an estimated 140 million to 170 million adults aged 45 to 74 in the eligible screening population. Across Asia, the eligible population exceeds 1.2 billion.
• Even modest improvements in screening rates could represent a multi-billion dollar healthcare opportunity annually, depending on test modality, screening interval, and pricing.
• The company’s progress with CADENCE CRC builds on its successful multi-market approval of GASTROClear, reinforcing Mirxes’ strategy to advance early cancer detection for the top five prevalent and deadly cancers in Asia.

5. Critical Considerations for Shareholders

• Completion of enrolment in the CADENCE CRC study is a significant milestone and may be price sensitive, as successful outcomes could unlock a vast, underserved market and drive revenue growth.
• The company is positioning for commercial launch by mid-2026, contingent on positive data and regulatory requirements.
• Cautionary Statement: There is no guarantee that further approval will be obtained or that CADENCE CRC will be successfully developed and marketed. Investors should be aware of inherent risks in clinical development and regulatory processes.

Disclaimer: The above is a summary and analysis of Mirxes Holding Company Limited’s announcement regarding the completion of enrolment in the CADENCE CRC study. This article is intended for informational purposes only and does not constitute investment advice. Please refer to official company filings and consult with financial advisors before making investment decisions. The company has highlighted that success is not guaranteed and regulatory approval is pending.

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