Core Insights - Mirxes Holding Company Limited has completed the enrollment for its prospective clinical study CADENCE CRC, marking a significant milestone as it transitions to laboratory analysis and data evaluation, with results expected by 2026 [1][2] Group 1: Study Overview - The CADENCE CRC study, initiated in 2023, aims to recruit 6,000 participants from diverse ethnic backgrounds in Southeast Asia, enhancing the universality and clinical relevance of the data [2] - This study utilizes colonoscopy as the gold standard to rigorously assess the effectiveness and safety of Mirxes' blood test for colorectal cancer, driven by its proprietary miRNA multi-omics platform [2] - CADENCE CRC is noted as the largest blood-based colorectal cancer screening clinical study in the ASEAN region, focusing on early screening, which differentiates it from other approved products in the market [2] Group 2: Market Context - The Asian colorectal cancer screening market has surpassed 100 billion yuan, with a growing demand for non-invasive, convenient, and precise blood tests, positioning Mirxes' offerings to fill a significant market gap [2][3] - Single cancer screening remains dominant in the global early screening market, supported by clear clinical evidence and regulatory pathways, while multi-cancer screening faces challenges in clinical validation [3] Group 3: Technological Advantage - Mirxes leverages its unique miRNA technology platform to differentiate itself in a competitive early screening landscape, achieving commercialization that few global companies have accomplished [4] - The company targets the ASEAN and China markets, addressing the low screening coverage due to accessibility and resource distribution issues, thereby establishing a comprehensive clinical and commercial network in Asia [4]

Core Viewpoint - MIRXES-B has completed the enrollment process for the CADENCE CRC study, a large-scale prospective clinical trial aimed at validating the effectiveness of its blood test for colorectal cancer screening in average and high-risk adult populations [1][4]. Group 1: Study Overview - CADENCE CRC is the largest registration study in Southeast Asia to evaluate blood-based colorectal cancer screening tests, recruiting over 6,000 participants from diverse ethnic backgrounds [1][2]. - The study is designed as a prospective validation research to support regulatory approval and clinical adoption of the blood test, with participants undergoing standard colonoscopy as a reference method [1][2]. - Enrollment began in 2023, with a target of 6,000 participants to be reached by early 2026, marking a key milestone for the company [1]. Group 2: Blood Test Technology - The blood test evaluated in CADENCE CRC is driven by the company's proprietary miRNA-centered multi-omics platform, integrating tumor-derived signals, non-tumor host response signals, and AI-driven machine learning algorithms [2]. - Previous studies have shown that the test has a sensitivity of over 80% and a specificity of approximately 90% for detecting early-stage colorectal cancer [2]. Group 3: Market Potential - The proposed laboratory-developed test (LDT) will leverage the company's existing laboratory infrastructure and clinical network in Southeast Asia, aiming for early market access while pursuing broader regulatory approvals [3]. - Colorectal cancer remains a leading cause of cancer-related deaths in Asia, with an estimated 140 to 170 million adults aged 45 to 74 in Southeast Asia recommended for screening [3]. - Despite the large high-risk population, screening participation rates remain low, presenting significant medical opportunities, with the potential market for screening tests in Southeast Asia estimated to reach billions annually [3]. Group 4: Strategic Importance - The completion of the CADENCE CRC enrollment process marks an important step for the company in advancing early detection of the five most common and deadly cancers in Asia [4]. - The study reflects the company's commitment to providing rigorous clinical evidence for blood-based colorectal cancer screening solutions [4].