MSI Reference Standard

Background & Product Introduction

Microsatellite Instability (MSI) is a molecular biomarker associated with deficient DNA mismatch repair (dMMR), commonly observed in cancers such as colorectal, endometrial, and gastric cancers. MSI testing has become critical for guiding immunotherapy decisions, prognosis assessment, and Lynch syndrome screening. To ensure accuracy and reproducibility in MSI detection, highly validated reference standards are essential. Our MSI Reference Standards are precisely designed to serve as reliable controls for clinical laboratories, in vitro diagnostic (IVD) developers, and researchers. They mimic real-world biological samples with certified MSI status (MSI-High, MSI-Low, or MSS) to validate assays across platforms, including PCR and next-generation sequencing (NGS).

Key Features

• Comprehensive Validation: Precisely characterized using gold-standard methods (e.g., PCR fragment analysis or NGS) and aligned with FDA/CLIA guidelines.

• Multiplex Coverage: Includes a panel of NCI-recommended microsatellite loci (BAT25, BAT26, etc.) and additional markers for enhanced specificity.

• Traceability & Stability: Manufactured under stringent quality controls with batch-to-batch consistency and long-term stability documentation.

• Flexibility: Compatible with mainstream MSI detection platforms and customizable to meet diverse workflow requirements.

Applications

• Clinical Validation: Verify assay sensitivity/specificity for labs implementing MSI testing.

• IVD Development: Accelerate regulatory approval of diagnostic kits by providing robust performance data.

• Research Tools: Facilitate studies on MSI-driven tumorigenesis, therapy resistance, or biomarker discovery.

• Quality Assurance: Monitor intra-lab variability and ensure compliance with accreditation standards.

Crafted for precision and reliability, our MSI Reference Standards empower laboratories to deliver confident results, advancing personalized oncology and precision diagnostics.