Empowering Immunotherapy Companion Diagnostics
Precise.Validated TMB Reference Standards for tissue and liquid biopsy assays
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CBP80001-1/2/3/4/5/6/7/8
CBP80001-1/2/3/4/5/6/7/8
Product Introduce
Tumor Mutational Burden (TMB) Reference Standards
TMB measures the number of somatic mutations per megabase of the tumor genome. It is a validated pan-cancer biomarker for immune checkpoint inhibitor response (FDA-approved for TMB-H ≥10 mut/Mb).
CB-Gene’s TMB diagnostic reference standards are designed to help IVD developers and clinical labs accurately assess the limit of detection, linearity, and reproducibility of their TMB assays. Our portfolio includes tissue-simulating (tTMB) and blood-based (bTMB) standards, with TMB scores ranging from 5.37 to 27.15 mut/Mb – including critical values around the 10 mut/Mb clinical cutoff.
Product Advantages
Precisely quantify tumor mutational burden with our complete panel of tissue and blood-based reference standards. Validated by WES, covering a full TMB range (5–27 mut/Mb) to support assay development, regulatory submission, and routine quality control.
Gold-standard validation
TMB scores derived from whole-exome sequencing (WES) compared to matched normal samples.
Wide gradient coverage
Low, medium, and high TMB values (5.37, 8.98, 9.84, 12.41, 21.09, 22.91, 27.15 mut/Mb) for linearity and accuracy studies.
tTMB & bTMB formats
Both tissue-mimicking reference standards and circulating tumor DNA (ctDNA) blood-based standards.
Limit-of-detection assessment
Available with different tumor content percentages and allele frequency (AF) cutoffs.
Matrix control
Negative/matrix standard (CBP80001-9) for background evaluation.
Application
IVD Kit Development & Performance Verification
Testing Sensitivity, Accuracy & Specificity of Experimental Methods
Daily QC Monitoring of NGS Library Preparation & Sequencing Runs
Company Advantage
We stands out with a strong foundation in precision diagnostics and a commitment to high-quality, reliable products
Scientific Quality Management
With our ISO9001 certification, we adhere to a stringent quality management system, ensuring that all our products meet the highest standards of accuracy, stability, and consistency.
Experienced and Skilled Team
Backed by a talented team of experts, we leverage advanced technology and extensive experience to drive innovation in molecular diagnostics, ensuring we stay at the forefront of the industry.
Advanced Laboratories
Our lean laboratories, located in Shanghai and Nanjing, China, are equipped to provide continuous and stable high-quality products, supporting both large-scale production and personalized customer needs.
Comprehensive Product Range
We offer a complete set of reference materials, including SNP, Indel, CNV, Fusion, NIPT, and more, covering a wide array of diagnostic needs and offering customized services for a variety of applications.
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We're here to assist you! Whether you have questions about our products, services, or need technical support, our team is ready to provide you with the information you need. Reach out to us today!
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