Seraseq® FFPE TMB Reference Material (Score 13 mut/Mb). FFPE QC for NGS TMB assay development, validation, and ICI biomarker testing.
The Seraseq® FFPE TMB Reference Material (Score 13) is a formalin-fixed, paraffin-embedded (FFPE) reference material engineered to a defined Tumour Mutational Burden (TMB) score of 13 mutations per megabase (mut/Mb). Designed for the development, validation, and quality control of NGS-based TMB assays using FFPE tumour specimens, it enables calibration across multiple TMB score levels.
TMB is an established predictive biomarker for response to immune checkpoint inhibitor (ICI) therapy. Accurate, reproducible TMB quantification from FFPE tissue is essential for patient selection and clinical decision-making.
Key features:
- FFPE format — mimics clinical FFPE tumour specimens throughout the extraction workflow
- Defined TMB score of 13 mut/Mb for accurate calibration and QC
- Supports development and validation of FFPE-based NGS TMB assays
- Enables inter-laboratory harmonisation and TMB assay benchmarking
- Relevant to ICI therapy biomarker testing and companion diagnostic development