Microsatellite instability (MSI) is a tumor molecular phenotype resulted from genomic hypermutability. MSI-affected tumors may, accordingly, result from mutational inactivation or epigenetic silencing of genes in the MMR pathway. MSI is a key immune biomarker in colorectal cancer (CRC), with crucial diagnostic, prognostic, and predictive implications. Therefore, testing for MSI status is critical for CRC treatment and should be recommended for all patients with newly diagnosed CRC. The study showed that MSI-H represents an important prognostic determinant and can be used to evaluate the recurrence risk in stage II CRC. Lynch syndrome is inherited in an autosomal dominant fashion, and resulted from a mutation in one allele of one of the DNA mismatch repair (MMR) genes. The phenotype indicating the MMR deficiency can be frequently observed as MSI in tumors. MSI-H is a known biomarker for anti-PD-1/PD-L1 immune checkpoint therapy. It is also a known tumor feature of Lynch syndrome. Therefore, MSI can be used for auxiliary diagnosis of Lynch syndrome and for the companion diagnosis of PD-1/PD-L1 immunosuppressive drugs.

MEDx Translational Medicine has established production workshops that meet the quality assurance requirements of ISO 13485, with a standard production process and strict quality control. Microsatellite Instability (MSI) Analysis Test (CE-IVD) is used for the in vitro qualitative detection of MSI status in neutral formalin-fixed, paraffin-embedded (FFPE) colorectal cancer tissues for the auxiliary diagnosis of hereditary non-polyposis colorectal cancer (HNPCC) and for the companion diagnosis of PD-1/PD-L1 immunosuppressive drugs.

MSI D-Water，   MSI 2×Buffer， MSI Reaction Enzyme，  

MSI 10× Primer mix， MSI Positive Quality Control， MSI Reagent Internal Reference DNA，

Nine Microsatellite Sites: BAT25、BAT26、BAT52、BAT56、BAT59、BAT60、MONO27、NR21、NR24

Applications

² Colorectal Cancer with Family History: Screening and identification of Lynch syndrome

² Stage II Colorectal Cancer: Medication guidance and prognostic assessment

² Advanced Colorectal Cancer: Assessing clinical benefit of immunotherapy

Competitive Advantages

² High Accuracy: Consistency as high as 96.8% compared with MMR IHC

² High Sensitive: Detection limit as low as 3ng, DNA mutation detection ratio as low as 10%.

² Good Stability：The reference product is verified for two consecutive days, multiple instruments, multiple operators, and multiple batches, and the sample test results meet the requirements.

² High Anti-interference：Under the interference of hemoglobin, triglyceride, EDTA anticoagulant, doxorubicin, cyclophosphamide, and gemcitabine hydrochloride, the product performance has no obvious effect.