Biocartis Idylla – MSI Assay LAUNCHED

Microsatellite Instability (MSI) shows a high mutational phenotype in cells that are deficient in one or more mismatch repair proteins 1. 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.

MSI testing importance

› MSI testing in the metastatic disease setting can assist clinicians in genetic counselling [II, B].

› MSI testing has strong predictive value for the use of immune checkpoint inhibitors in the treatment of patients with mCRC [II, B].
Reference: Van Cutsem E. et al. Annals of Oncology  2016

Idylla™ MSI Assay (RUO)

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 (RUO)

  • Fast and reliable information on MSI status 3,4,5
  • 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 methods 3,4,5
  • Significantly lower failure rate compared to standard methods 3,4,5
  • MSI-specific pan-tumor biomarkers independent of ethnicities 3,4,5
  • Unbiased result reporting
  • Number of mutated markers linked to degree of tumor mutational burden and total indel load6

Idylla™ MSI Assay (RUO) Tissue Specimen Requirements
1 x 5 µm FFPE tissue section → 50-600 mm2
1 x 10 µm FFPE tissue section → 25-300 mm2
Neoplastic cell content ≥ 20% (If < 20%, macrodissection needed)

Studies with Idylla™ MSI Biomarkers selected for ASCO Annual Meeting

VIEW ABSTRACTS HERE

Idylla™ MSI Assay (RUO) Downloads

IDYLLA™ MSI ASSAY (RUO) TECHNICAL SHEET

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.
6 Zhao et al. Association of a novel set of 7 homopolymer indels for detection of MSI with tumor mutation burden and total indel load in endometrial and colorectal cancers. Journal of Clinical Oncology 2018 36:15_suppl, e15654.
The Idylla™ MSI Assay is for Research Use Only. Not for use in diagnostic procedures.

For more information, please contact Tuuliki Biene tuuliki@inbio.ee.