Empowering Immunotherapy Companion Diagnostics

IVD Kit Development & Performance Verification

Our TMB reference standards are essential tools for manufacturers developing tissue and liquid biopsy TMB assays. They enable rigorous validation of linearity, limit of detection (LoD), limit of blank (LoB), and accuracy across the full TMB range – from low (5.37 mut/Mb) to high (27.15 mut/Mb). The inclusion of a matrix control (CBP80001-9) allows assessment of background noise and specificity. By using well-characterized tTMB and bTMB standards, IVD developers can confidently establish assay cutoffs and demonstrate analytical performance required for product launch.

Testing Sensitivity, Accuracy & Specificity of Experimental Methods

Our TMB reference standards provide a well-characterized panel of samples with known TMB values (5.37–27.15 mut/Mb). Researchers can use them to systematically evaluate the sensitivity (ability to detect true TMB-H samples), accuracy (deviation from expected TMB scores), and specificity (ability to correctly identify TMB-L and matrix controls) of their in-house or commercial TMB assays. This is essential for method development, cross-platform comparisons, and troubleshooting.

Daily QC Monitoring of NGS Library Preparation & Sequencing Runs

Consistent quality control is critical for reproducible TMB results. Our TMB reference standards can be integrated into routine NGS workflows as in-process controls. They monitor key steps including library preparation efficiency, sequencing depth uniformity, and variant calling reproducibility. With validated compatibility across Illumina, Thermo Fisher, and MGI Tech platforms, they help labs identify run-to-run variations and maintain data quality over time – all for research purposes.