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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

References

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.

Idylla™ MSI Mutation Assay is for Research Use Only. Not for use in diagnostic procedures.

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Biocartis is recruiting centers for a prospective biomarker study comparing turnaround times of standard of care methods and biomarker testing with Idylla™.

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.