Tongshu Gene Secures China's First NMPA Approval for MSI Detection Kit, Marking the Dawn of Regulated and Certified MSI Testing

Precise molecular diagnosis of tumors is a crucial prerequisite for improving the overall survival of cancer patients. Among various biomarkers, Microsatellite Instability (MSI) has garnered significant attention in the medical community due to its broad clinical implications, including aiding in the diagnosis of Lynch syndrome, prognostic assessment, prediction of adjuvant chemotherapy efficacy, and prediction of immunotherapy response in solid tumors. In particular, the unique immune sensitivity associated with MSI-High (MSI-H) tumors has become a focal point of industry interest. According to statistics,China’s Annual MSI-H Tumor Disease Burden Reaches Up to 324,000 Cases, with an extremely high disease burden. However, there is a lack of officially certified standardized products available for clinical oncology patients.

VCBeat has learned that the “Microsatellite Instability (MSI) Detection Kit (Multiplex Fluorescent PCR-Capillary Electrophoresis),” independently developed and manufactured by Changzhou Tongshu Biotechnology Co., Ltd. (TONGSHU GENE), has passed the review of the National Medical Products Administration (NMPA). Approved on January 26, 2021, the kit is indicated for the qualitative in vitro detection of the microsatellite status of five loci (“2B3D”: BAT-25, BAT-26, D5S346, D2S123, and D17S250) in formalin-fixed paraffin-embedded (FFPE) tumor tissue samples from patients with colorectal cancer. It has obtained China’s first Class III medical device certificate for microsatellite instability testing (National Medical Device Registration No. 20213400070).

TheThe kit is China’s first MSI detection kit based on “multiplex fluorescent PCR-capillary electrophoresis.”, this approval was granted after rigorous validation with extensive clinical samples and successful audit of the registered production quality system, following stringent review by the NMPA, which ultimately issued this landmark“The First Class III Certificate for MSI,” Also a “Milestone” in Domestic Tumor Genetic Testing!

Yan Linghua, founder of TONGSHU GENE, stated that the approval process for this MSI kit spanned nearly five years and was extremely arduous. Thanks to the sustained support from government leaders at all levels, industry experts, and all shareholders, we ultimately obtained approval from the National Medical Products Administration (NMPA). This market launch approval not onlyIt fills the gap in standardized testing for microsatellite instability (MSI) in China, putting an end to the era of “unapproved” MSI assays. More importantly, there is finally an approved product that will benefit over 300,000 cancer patients with MSI-H tumors in China each year.Concurrently, with the approval of this kit, MSI testing will officially be introduced into qualified hospitals and third-party clinical laboratories with the requisite testing capabilities. Undoubtedly, this represents a milestone in standardizing MSI testing within the oncology sector, assisting clinicians in formulating diagnosis and treatment plans, and benefiting a broader population of cancer patients!