On October 13, 2023 Geneseeq Technology Inc. reported 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 (Press release, Geneseeq, OCT 13, 2023, View Source [SID1234635959]).
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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.
Prior to this, Geneseeq already had one NGS-based CDx kit for NSCLC, ESSENCARE (EGFR/ALK/ROS1/BRAF/KRAS/HER2 mutation testing kit), approved by the NMPA through the Breakthrough Medical Devices pathway. GENESEEQPRIME was also CE-IVD marked by the European Medicines Agency in August 2023 for detecting single nucleotide variants, gene amplifications/deletions, translocations, TMB, and microsatellite instability in patients with solid tumors.
"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.