Amoy Diagnostics Co., Ltd (AmoyDx, SHE: 300685), a prominent player in the Chinese diagnostics industry, has announced that it has received a Category III medical device license from the National Medical Products Administration (NMPA) for its human microsatellite instability (MSI) detection kit. This kit, which utilizes fluorescent PCR capillary electrophoresis, is designed for the in vitro qualitative detection of MSI status in formalin-fixed paraffin-embedded (FFPE) tissue samples of solid tumor patients.
MSI Detection Kit’s Significance and Applications
The MSI status is determined by detecting five single nucleotide repeat markers, including BAT-26, BAT-25, MONO-27, NR-24, and CAT-25. Amoy’s product serves as a companion diagnostic (CDx) to BeiGene’s (NASDAQ: BGNE) programmed death-1 (PD-1) inhibitor tislelizumab. This approval positions Amoy’s MSI testing kit as the first approved pan-solid tumor immunotherapy CDx in China, marking a significant advancement in the field of personalized medicine.
Implications for Immunotherapy and Prognosis
MSI detection plays a crucial role in predicting the efficacy of immunotherapy for solid tumors and can also be employed to determine prognosis and predict the effectiveness of chemotherapy. This capability enhances clinical decision-making and personalizes treatment approaches for patients with solid tumors.-Fineline Info & Tech
