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AmoyDx® Microsatellite Instability (MSI) Detection Kit Received NMPA Approval for Pan-Tumor Immunotherapy Companion Diagnostics

Xiamen China, November 2, 2023 – National Medical Products Administration (NMPA) granted approval to AmoyDx® Microsatellite Instability (MSI) Detection Kit, making it the first-of-its-kind pan-cancer immunotherapy companion diagnostic kit for market in China. 

Immunotherapy is a monumental breakthrough for cancer treatment and has revolutionized the field of oncology. Immunotherapy drugs targeting PD-1, PD-L1 - including Keytruda, Opdivo, and Tislelizumab - have been widely used today. But not all patients would benefit from immunotherapy - only patients with high PD-L1 and MSI-H expression in the tumor cells are eligible for such treatment. Thus, the evaluation of PD-L1 and MSI is significant to guide treatment decisions for optimized patient outcomes. Indeed, it is also recommended by current guidelines. 

AmoyDx MSI detection kit is approved by NMPA as a companion diagnostic for pan-solid tumor immunotherapy. It is not only valuable for predicting immune efficacy but also for predicting disease prognosis, facilitating auxiliary diagnosis, and assessing chemotherapy efficacy. The approval of this kit, along with the concurrent detection of KRAS, NRAS, and BRAF genes, aligns with the gene detection requirements outlined in globally recognized guidelines for precise colorectal cancer treatment and enables comprehensive care management for colorectal cancer patients.

The NMPA also granted approval for AmoyDx® PD-L1 (E1L3N) assay in March 2022, read more here: 


About Amoy Diagnostics Co., Ltd. (AmoyDx, SZSE: 300685)
Amoy Diagnostics Co., Ltd. is a pioneer and globally leading company in the field of molecular diagnostics for precision oncology, focusing on companion diagnostics product development and commercialization. A rich product portfolio has been established with more than 20 products approved by China NMPA, EU authority, Japan MHLW, South Korea MFDS, etc. Patients in more than 60 countries are benefiting from AmoyDx products. With multiple technological platforms and full capability for companion diagnostics product development and commercialization, AmoyDx has become an important diagnostics partner of many pharmaceutical companies over the globe.


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