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.
This NSCLC TMB kit entered the NMPA special examination and approval procedures for Breakthrough Medical Devices in January 2020. 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™). TMB is a predictive biomarker for the efficacy of immune checkpoint inhibitor therapy.
“This approval will significantly benefit the clinical implementation of immunotherapy in China with a standardized TMB assessment assay,” Dr. Yang Shao, founder and CEO of Geneseeq Group, said in a statement.
Source: Company Press Release
