By Fineline Cube 
Guangzhou-based Wondfo Biotech (SHE: 300482) announced that the National Medical Products Administration (NMPA) has granted marketing clearance (certificate No. 20253401409, valid until July 16, 2030) for its self-developed microsatellite-instability (MSI) detection kit. This marks the first time a fluorescent PCR melting-curve methodology has been approved for MSI detection in China.
Innovative Diagnostic Tool
The in-vitro diagnostic kit is designed for the qualitative assessment of eight microsatellite loci in formalin-fixed, paraffin-embedded (FFPE) colorectal-cancer tissue. This allows clinicians to classify tumors as MSI-high or non-MSI-high with greater precision.
Clinical and Market Significance
MSI status is a critical molecular signature across multiple malignancies. It plays a pivotal role in Lynch-syndrome screening, chemotherapy selection, prognosis evaluation, and identifying patients who are likely to benefit from immunotherapy. Wondfo’s MSI detection kit provides a valuable tool for oncologists, enhancing personalized treatment strategies for colorectal cancer patients.-Fineline Info & Tech