Clinical Trial Sample Analysis

Theragen Bio provides expert service for exploratory analysis and companion diagnostics development using biospecimens from patients enrolled in clinical trials. We have special expertise in dealing with FFPE samples. Each project is managed by the CTO with globally recognized expertise in FFPE sample analysis.

Features & Benefits

• Support for reliable bioinformatics analysis specialized in clinical trials : For hundreds of samples extracted from FFPE samples such as lung cancer, stomach cancer, and colorectal cancer from leading pharmaceutical companies in Korea, we successfully complete clinical trial orders for combination drug administration through high library production and mutation analysis.
• Provide an advanced platform for FFPE sample data analysis : We provide an optimized pipeline for each variation that minimizes false positive caused by DNA deamination extracted from FFPE samples.
• Support for biomarker discovery based on deeplearning and spatial genomics : We support for biomarker discovery based on deeplearning and spatial genomics linked to bigdata.
• Theragen Bio obtains the reliability and competitiveness of clinical trial analysis through the entire research phases with globally genetic testing technology by proving neoantigen development and diagnosis technology.

Featured Services

Globally recognized expertise in the analysis of FFPE samples from multicenter clinical trials

• Developed QC standard for FFPE samples
  - Optimized sample preparation and QC process for detection of mutations from FFPE samples
• Optimized methods for DNA extraction from FFPE samples and sequencing library construction
  - High success rate of producing library using small amount of tissue samples
• Support for biomarker discovery and companion diagnostics development
  - Support for study design and data analysis with the aim of companion diagnostics development)
  - Support for biomarker discovery based on spatial genomics using GeoMx and Visium

Applications

Evaluation of known prognostic and predictive markers

• Support for genome sequencing throughout pre-clinical development and clinical trials
• Evaluation of known biomarkers in pre-clinical and clinical samples



Development of companion diagnostics

• Planning for development of companion diagnostics
• Support for embedded biomarker studies for clinical protocols
• Execution of the experiments to develop and validate companion diagnostics

Key Benefits

• Globally recognized expertise of CTO with more than 20 years experience in multicenter clinical trials and companion diagnostics development using FFPE samples
• Support by the CTO and dedicated research director for the project from pre-consultation to completion
• Provision of customized analysis for specific regulatory submission requirements
• Gurantee for trustworthy data quality

SOP Process

Theragen Bio provides reliable and high-quality results with project-specific support from a dedicated research director

Deliverables

Data packages and customized reports provided

• Materials method & procedures
• Analysis report
• Certificate of analysis (COA)
• Signed the QAU statement