诺奖级技术突围战，觅瑞撬动千亿癌症早筛市场

Core Insights - The global cancer early screening market is experiencing rapid expansion, particularly in the gastric cancer screening sector, which has grown from $13 billion in 2019 to $15.2 billion in 2023, with projections to exceed $25 billion by 2033 [1][3] - Mirxes, a pioneer in miRNA technology, has developed GASTROClearTM, the world's first approved miRNA gastric cancer early screening kit, which offers a non-invasive, cost-effective, and convenient alternative to traditional screening methods [1][6] Market Growth - The gastric cancer screening market in China, Japan, Southeast Asia, and the U.S. is expected to see a compound annual growth rate (CAGR) of 4.1% from 2019 to 2023, accelerating to a projected CAGR of 6.8% from 2023 to 2028 [3][4] - The penetration rate of gastric cancer screening in high-risk populations in China has increased from 21.6% in 2019 to 27.8% in 2023, with expectations to rise to 67% by 2033 [4] Technological Advancements - Mirxes has successfully commercialized miRNA early screening products, overcoming significant challenges in the industry related to the detection of subtle differences between miRNAs [5][7] - GASTROClearTM has demonstrated a high sensitivity of 87% for overall gastric cancer detection, with specific sensitivities of 87.5% for stage I cancer and 75% for lesions smaller than 1 cm [9] Business Strategy - Mirxes plans to initially offer GASTROClearTM as a laboratory-developed test (LDT) to build brand awareness before transitioning to in vitro diagnostic (IVD) product sales [2] - The company has submitted an IPO application to the Hong Kong Stock Exchange, aiming to leverage its unique miRNA technology for rapid market expansion [1][10] Financial Performance - In 2024, GASTROClearTM generated $6.278 million in revenue, accounting for 30.9% of total revenue, with a gross profit of $1.9234 million and a gross margin of 70.6% [10][11] - The detection volume for GASTROClearTM doubled in 2024 compared to 2023, reaching 106,600 tests, indicating strong market demand and operational efficiency [10] Future Outlook - Mirxes is set to launch GASTROClearTM as an IVD product in China by mid-2025, following the completion of clinical trials and submission of registration applications [11] - The company has secured $40 million in strategic financing to support the commercialization of GASTROClearTM in the Asia-Pacific market and accelerate clinical validation of other product lines [11]