XIAMEN CHINA – May 20, 2026 – Amoy Diagnostics Co., Ltd. (AmoyDx, SZSE: 300685), a leading innovator in precision oncology molecular diagnostics, announced that its AmoyDx® MSI PCR Kit has received marketing approval from the National Medical Products Administration (NMPA) of China (Registration No. 20263401021).
This major milestone expands AmoyDx’s robust colorectal cancer (CRC) testing portfolio, providing hospitals and laboratories with an accurate, efficient, and highly accessible solution for assessing microsatellite instability (MSI) status.
The AmoyDx® MSI PCR Kit is designed for the qualitative in vitro detection of microsatellite instability (MSI) status in formalin-fixed, paraffin-embedded (FFPE) tumor tissue samples from colorectal cancer patients. By tracking variations in microsatellite lengths across six novel biomarkers - EIF4E3, IFT140, UBAC2, PRR5-ARHGAP8, ACVR2A, and RBM14-RBM4 - the kit identifies defects in the mismatch repair (dMMR) mechanism.
MSI-H status is a critical biomarker in colorectal cancer, guiding immunotherapy decisions (e.g., PD-1 inhibitors), predicting prognosis, and supporting treatment planning. By expanding access to reliable MSI testing, the new kit helps enable more colorectal cancer patients to benefit from precision medicine.
About Amoy Diagnostics Co., Ltd. (AmoyDx, SZSE: 300685)
AmoyDx is at the forefront of championing molecular diagnostics for cancer, committed to enhancing patient outcomes worldwide through innovative diagnostic solutions and breaking barriers for global precision oncology adoption. The company is recognized for its excellence in precision medicine, driving advancements in cancer diagnosis through its extensive collaboration with pharmaceutical companies. For more information, please visit www.amoydiagnostics.com, or follow us at LinkedIn and X.
This major milestone expands AmoyDx’s robust colorectal cancer (CRC) testing portfolio, providing hospitals and laboratories with an accurate, efficient, and highly accessible solution for assessing microsatellite instability (MSI) status.
The AmoyDx® MSI PCR Kit is designed for the qualitative in vitro detection of microsatellite instability (MSI) status in formalin-fixed, paraffin-embedded (FFPE) tumor tissue samples from colorectal cancer patients. By tracking variations in microsatellite lengths across six novel biomarkers - EIF4E3, IFT140, UBAC2, PRR5-ARHGAP8, ACVR2A, and RBM14-RBM4 - the kit identifies defects in the mismatch repair (dMMR) mechanism.
MSI-H status is a critical biomarker in colorectal cancer, guiding immunotherapy decisions (e.g., PD-1 inhibitors), predicting prognosis, and supporting treatment planning. By expanding access to reliable MSI testing, the new kit helps enable more colorectal cancer patients to benefit from precision medicine.
About Amoy Diagnostics Co., Ltd. (AmoyDx, SZSE: 300685)
AmoyDx is at the forefront of championing molecular diagnostics for cancer, committed to enhancing patient outcomes worldwide through innovative diagnostic solutions and breaking barriers for global precision oncology adoption. The company is recognized for its excellence in precision medicine, driving advancements in cancer diagnosis through its extensive collaboration with pharmaceutical companies. For more information, please visit www.amoydiagnostics.com, or follow us at LinkedIn and X.
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