[Clinical Application of NGS-Based Clinical Sequencing]

Area of Science:

• Oncology
• Genomics
• Molecular Diagnostics

Background:

• Cancer clinical sequencing is crucial for tailoring treatment plans to individual patients.
• Its application is rapidly expanding in Japan, transforming cancer care.
• Formalin-fixed paraffin-embedded (FFPE) tumor samples are commonly used for this analysis.

Purpose of the Study:

• To outline the process and requirements for cancer clinical sequencing.
• To highlight the importance of quality assurance in clinical sequencing workflows.
• To emphasize the necessity of expert teams for generating clinical sequencing reports.

Main Methods:

• Amplicon sequencing is performed on FFPE tumor samples obtained via biopsy or resection.
• The clinical sequencing process is divided into pre-analysis, analysis, and post-analysis stages.
• Next-generation sequencing (NGS) analysis forms the basis for clinical sequencing reports.

Main Results:

• The study details the multi-stage process of cancer clinical sequencing.
• It underscores the critical role of quality assurance and control throughout all procedural steps.
• The necessity of expert interpretation for generating actionable clinical sequencing reports is confirmed.

Conclusions:

• Cancer clinical sequencing is an evolving method for personalized cancer treatment.
• Robust quality control and expert review are essential for reliable clinical sequencing outcomes.
• The integration of NGS analysis into clinical practice is vital for advancing cancer therapy.