MSI Reference Standards
Enabling Microsatellite Instability Detection
Enabling Microsatellite Instability Detection
MSI Reference Standards—Reliable MSI and MSS reference materials for PCR and NGS workflows..
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CBP80002-5/6/7/8/9/10/11/12
CBP80002-5/6/7/8/9/10/11/12
Product Introduce
Microsatellite Instability (MSI) Reference Standards
Microsatellite instability (MSI) results from insertion or deletion mutations in short tandem repeats, often caused by deficient mismatch repair (dMMR). MSI is a key biomarker for Lynch syndrome screening and immunotherapy response (e.g., pembrolizumab for MSI-H solid tumors).
CB-Gene’s MSI diagnostic reference standards cover both microsatellite stable (MSS) and MSI-high (MSI-H) statuses, with pre‑characterized instability percentages ranging from 1.92% to 100%. These standards are compatible with PCR‑fragment analysis and NGS platforms, supporting assay development, optimization, and routine quality control.
Product Advantages
our MSI Reference Standards empower laboratories to deliver confident results, advancing personalized oncology and precision diagnostics.
Comprehensive validation
Precisely characterized using gold‑standard methods (PCR fragment analysis and NGS), aligned with FDA/CLIA guidelines.
Multiplex locus coverage
Includes NCI‑recommended loci (BAT25, BAT26, D5S346, D2S123, D17S250) and additional markers (NR‑21, NR‑24, MONO‑27) for enhanced specificity.
Wide instability gradient
MSS (stable) and MSI‑H samples with pre‑determined instability percentages (1.92% – 100%).
Traceability & stability
Manufactured under strict quality controls with batch‑to‑batch consistency and long‑term stability documentation.
Platform flexibility
Compatible with mainstream MSI detection methods: PCR‑capillary electrophoresis and NGS panels.
Ready‑to‑use
Pre‑characterized MSI status and percentage values – no additional bioinformatics required.
Application
Clinical Validation of MSI Assay Performance
IVD Kit Development & Research‑Use Kit Optimization
Daily Quality Assurance & Translational Research
Company Advantage
We reference 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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