For professional/laboratory use only.
The Idylla™ MSI Test is intended for the qualitative detection of a novel panel of seven monomorphic homopolymer biomarkers for identification of colorectal cancers (CRC) with microsatellite instability (MSI).
The Idylla™ MSI Test uses formalin-fixed, paraffin-embedded (FFPE) tissue sections from human CRC tissue, from which nucleic acids are liberated, then analyzed by PCR amplification and high-resolution melting detection. The Idylla™ MSI Test automates the entire process from FFPE sample preparation to reporting of MSI status. The fully automated IdyllaTM MSI Test performs the detection of microsatellite instability directly from formalin-fixed paraffin embedded (FFPE) human cancer tissue sections utilizing a PCR reaction followed by high-resolution melting curve analysis. The fully automated samples-to-result process with integrated automated software interpretation and reporting makes this MSI analysis fast and easy-to-use in virtually any laboratory setting.
The fully automated IdyllaTM MSI Test performs detection of mutations in 7 novel MSI loci (ACVR2A, BTBD7, DIDO1, MRE11, RYR3, SEC31A, and SULF2). These biomarkers are tumor-specific, show a high frequency in colorectal cancer and are stable across different ethnicities ensuring excellent specificity of the test. In addition, these tumor-specific biomarkers do not require the analysis of paired normal tissue samples associated with traditional MSI/dMMR testing. With its high concordance (> 97%) and low failure rates compared to standard methods, the IdyllaTM MSI Test provides a fast, convenient and reliable alternative for any lab.
· 7 novel tumor-specific biomarkers
· 150 minutes assay turnaround time
· <2 minutes hands-on time
· No need for paired tissue
· Highly sensitive & standardized
· Unbiased result reporting