NIPT Reference Standard

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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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

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!

FAQs

Q: What MSI statuses and instability percentages do your standards cover?
We offer both MSS (microsatellite stable) and MSI‑H (MSI‑high) standards. Instability percentages range from 1.92% to 100% (e.g., MSS‑P1 at 1.92%, MSI‑H‑U1 at 100%). This allows you to evaluate assay performance across the full spectrum.
Q: Which microsatellite loci are included in your reference standards?
Our standards cover the NCI‑recommended panel (BAT25, BAT26, D5S346, D2S123, D17S250) as well as additional mononucleotide markers (NR‑21, NR‑24, MONO‑27) for enhanced specificity, compatible with both classic PCR and Promega‑style panels.
Q: Are these standards compatible with NGS‑based MSI detection?
Yes. Our MSI reference standards are validated for NGS platforms (Illumina, Thermo Fisher, MGI Tech) as well as traditional PCR‑capillary electrophoresis. They can be used to optimize panel design, bioinformatics pipelines, and cutoff determination.
Q: Can I request custom MSI reference standards with specific instability percentages or unique loci?
Yes. We offer customization services, including specific MSI percentages, custom microsatellite loci, or matrix backgrounds. Please contact our technical team to discuss your research needs.
Q: How can I request a quote or technical datasheet?
Please contact our team at sales@cb-gene.com or visit our website. We offer free technical consultation, sample applications, and custom‑sized packaging.

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