The kit qualitatively detects TMB in FFPE tissue samples of patients with EGFR/ALK-negative non-squamous NSCLC. Credit: 15Studio/Shutterstock.com.

The Chinese National Medical Products Administration (NMPA) has granted approval as a breakthrough medical device for Geneseeq Technology’s non-small cell lung cancer tumour mutational burden test (NSCLC TMB) kit.

In January 2020, the kit underwent the NMPA special examination and approval procedures required to get breakthrough medical device status.

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By utilising the reversible terminator sequencing method, the kit can be used for in vitro detection of TMB in FFPE tissue samples of patients with EGFR/ALK-negative non-squamous NSCLC.

TMB serves as a predictive biomarker for the efficacy of immune checkpoint inhibitor therapy.

The NSCLC TMB Kit is claimed to be the first next-generation sequencing (NGS)-based kit to be approved in China, with a large gene panel covering 425 cancer-associated genes (GENESEEQPRIME).

In August this year, GENESEEQPRIME received CE-IVD mark approval from the European Medicines Agency for detecting single nucleotide variants, gene amplifications/deletions, translocations, TMB and microsatellite instability in patients suffering from solid tumours.

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Commenting on the NMPA approval, Geneseeq Group founder and CEO Dr Yang Shao said: “This approval will significantly benefit the clinical implementation of immunotherapy in China with a standardised TMB assessment assay.”

The company also received NMPA approval for ESSENCARE (EGFR/ALK/ROS1/BRAF/KRAS/HER2 mutation testing kit), an NGS-based CDx kit, for NSCLC.

In January this year, Geneseeq’s multi-cancer minimal residual disease detection and multi-cancer early detection kits gained a CE mark for liquid biopsy use in solid tumour patients.