GENESEEQ RECEIVES CHINESE NMPA APPROVAL FOR LUNG CANCER TUMOR MUTATIONAL BURDEN NGS TEST KIT (Canada Newswire)
"Geneseeq Technology Inc. announced on Thursday that Geneseeq's Non-Small Cell Lung Cancer Tumor Mutational Burden Test Kit (Reversible terminator sequencing method) (NSCLC TMB Kit) has gained approval from the Chinese National Medical Products Administration (NMPA) on October 12, 2023 as a Breakthrough Medical Device....With the NMPA approval, this kit is used for in vitro qualitative detection of TMB in FFPE tissue samples from patients with EGFR/ALK-negative non-squamous NSCLC...This is the first next-generation sequencing (NGS)-based TMB test kit approved in China with a large gene panel covering 425 cancer-associated genes (GENESEEQPRIME™)."