NEW YORK – Geneseeq Technology said Friday that its Non-Small Cell Lung Cancer Tumor Mutational Burden Test Kit to measure the efficacy of immune checkpoint inhibitor therapy has received approval from China's National Medical Products Administration (NMPA) as a breakthrough medical device.
The Toronto-based firm's test kit uses next-generation sequencing for qualitative detection of tumor mutational burden in FFPE samples from patients with EGFR/ALK-negative non-squamous NSCLC. It relies on reversible terminator sequencing for its panel of 425 genes associated with cancer.
The firm said the kit is the first NGS-based tumor mutational burden test kit approved in China.
"This approval will significantly benefit the clinical implementation of immunotherapy in China with a standardized TMB assessment assay," Geneseeq CEO Yang Shao said in a statement.
The company noted that it previously received approval in China for its NGS-based Essencare mutation test for EGFR, ALK, ROS1, BRAF, KRAS, and HER2 in NSCLC patients. The firm received CE marks in January for its multi-cancer minimal residual disease detection and multi-cancer early detection kits for use with solid tumors, and it also received CE marks in August for its GeneseeqPrime and GeneseeqPrime HRD kits for NGS-based solid tumor profiling as well as for its Hemasalus DNA/Hemarna RNA kits for NGS-based profiling of hematological malignancies.