Microsatellite Instability (MSI) shows a high mutational phenotype in cells that are deficient in one or more mismatch repair proteins¹. MSI is present in many different cancer types, but is most common in colorectal cancer (10-15%), gastric cancer (10-20%), and endometrial cancer (20-30%)¹,². Current MSI testing methods rely on manual, lengthy and complex procedures, involving amongst others obtaining and testing a second reference sample.
The Idylla™ MSI Assay (RUO) performs the detection of microsatellite instability directly from formalin-fixed paraffin embedded (FFPE) human cancer tissue sections with less than 2 minutes of hands-on time. The Idylla™ MSI Assay (RUO), performed on the Biocartis Idylla™ system, utilizes a PCR reaction followed by high-resolution melting curve analysis. The Idylla™ MSI Assay directly liberates DNA from FFPE tissue for subsequent analysis. Fully automated software interpretation and reporting is also integrated, providing a result in approximately 150 minutes.
This sample-to-result assay is intended for the qualitative detection of mutations in 7 novel MSI loci (ACVR2A, BTBD7, DIDO1, MRE11, RYR3, SEC31A, and SULF2). Additionally, since the Idylla™ MSI biomarkers are tumor specific, there is no normal tissue required for analysis and MSI status determination.
Idylla™ MSI Assay Product Highlights
• Fast and reliable information on MSI status3,4,5
• Fully-automated detection of MSI status via 7 novel MSI loci
• Directly from a single slice of FFPE tissue – no normal tissue required for comparison
• 150 minutes total turn-around time with less than 2 minutes hands-on time
• >95% concordance in a multi-center concordance analysis with standard methods3,4,5
• Significantly lower failure rate compared to standard methods3,4,5
• MSI-specific pan-tumor biomarkers independent of ethnicities3,4,5
• Unbiased result reporting
1.Bonneville et al. Landscape of MSI across 39 cancer types. JCO Precision Oncology ASCO 2017.
2.Richman S et al. International Journal of Oncology 2015.
3.Maertens et al. Detection of microsatellite instability (MSI) with the Idylla™ MSI Test in colorectal cancer samples. Annals of Oncology (2017) 28 (suppl_5): v22-v42.
4.De Craene et al. Detection of microsatellite instability (MSI) with a novel panel of biomarkers in gastric cancer samples. Annals of Oncology (2017) 28 (suppl_5): v209-v268.
5.Based upon internal research data.
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DISCLAIMER:
This information concerns a use that has not been approved or cleared by the Food and Drug Administration.
Biocartis is recruiting centers for a prospective biomarker study comparing turnaround times of standard of care methods and biomarker testing with Idylla™.
DISCLAIMER:
This presentation is intellectual property of the individual presenters. The opinions and conclusions expressed in these presentations are those of the individual presenters and do not necessarily reflect the views and opinions of Biocartis and/or its employees.
One of the biggest challenges oncology labs face with 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. For solid biopsies, just one slice of tissue is enough and our plasma-based assays require only 1 ml of plasma.
