China-based Nanjing Geneseeq Medical Device and Diagnostic Inc. has announced that its tissue tumor mutation burden (TMB) detection kit, utilizing a reversible end termination sequencing method, has received marketing approval from the National Medical Products Administration (NMPA). This marks the kit as the 231st novel medical device approved in China.
In Vitro Detection for Enhanced Treatment Strategies
The detection kit is designed for in vitro qualitative assessment of TMB in formalin-fixed paraffin-embedded (FFPE) tissue samples collected from non-small cell lung cancer (NSCLC) patients, specifically those with negative EGFR gene mutations and negative ALK alterations. TMB serves as a predictive biomarker for assessing the therapeutic efficacy of immune checkpoint inhibitors, offering valuable insights into treatment options.
High-Throughput Sequencing Technology for Tumor Analysis
Utilizing advanced high-throughput sequencing technology, the kit can analyze 425 genes to accurately calculate tumor mutation loads. Clinical research indicates that patients with high tumor mutation burdens who are treated with the anti-tumor drug camrelizumab in conjunction with chemotherapy experience significantly prolonged progression-free survival compared to those with lower mutation loads.-Fineline Info & Tech
