Idylla MSI Test (CE-IVD)
A0100/6
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.
Specimen requirements
One of the biggest challenges in oncology biomarker testing is the ability to obtain samples of sufficient size and quality. With the Idylla™ System only a minimal amount of sample is needed
- 1x 5 μm FFPE tissue section -> 50-600 mm²
- 1x 10 μm FFPE tissue section -> 25-300 mm²
- Neoplastic cells ≥20% - if less, macrodissection is required
