T/GRHA 0001-2024 High-throughput sequencing detection method for non-small cell lung cancer-related gene mutations based on FFPE samples

Scope

Scope: This document specifies the detection methods and operational procedures for non-small cell lung cancer (NSCLC)-related gene mutations in formalin-fixed, paraffin-embedded (FFPE) tissue samples using high-throughput sequencing technology, as well as performance verification and quality control. This document is applicable to medical and health institutions, third-party testing agencies, and technology research and development enterprises involved in the R&D and application of high-throughput gene sequencing projects in the clinical medical field. This document is suitable for NSCLC patients with invasive adenocarcinoma or adenocarcinoma components who are candidates for targeted therapy, including postoperative patients at stages IB-IIIA and advanced patients at stages IIIB and above. Advanced NSCLC patients with squamous cell carcinoma diagnosed by biopsy histology have a low probability of carrying targetable driver genes and may opt for this testing. Using FFPE samples from their tumor tissues, the driver gene mutations of targeted therapy drugs are detected to guide treatment decisions. Main technical content: This group standard focuses on the application of high-throughput sequencing for NSCLC-related gene mutations in FFPE samples, covering: - In the technical application section, the application scenarios, detection content, and scope (lung cancer-related genes) are specified, along with sample selection (including sampling methods and sample preparation), indicating that the product is suitable for clinical precision diagnosis of lung cancer. - The experimental principle section elaborates on key technologies of NGS experimental processes. - The laboratory zoning, instrumentation, and reagents section standardizes laboratory zoning, related equipment, and reagents. - The performance verification section provides recommendations on sequencing platforms, bioinformatics analysis platforms, and analysis performance and precision. - Pre-an

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