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TECHNICAL SHEET IDYLLA™ MSI TEST
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.
FEATURES
Idylla™ MSI Biomarkers
ACVR2A 2q22.3-q23.1
BTBD7 14q32.12
DIDO1 20q13.33
MRE11 11q21
RYR3 15q13.3-q14
SEC31A 4q21.22
SULF2 20q13.12
Sample Processing Control
The MSI specific software will automatically check the validity of the
measured fluorescence profiles: presence of specific PCR amplicons will
result in biomarker-specific fluorescence profiles, which eliminates the need
for an additional sample processing control in the cartridge.
Specimen requirements
Sample type FFPE tissue sections (5-10 µm)
Neoplastic cells > 20%, if less, macrodissection is required
Tissue area50–600 mm² (5 µm)
25-300 mm² (10 µm)
MSI
1
CE IVD
Total turnaround time
Time 150 minutes
Performance
Analytical sensitivity 10% LOD
Between Laboratory Reproducibility
(480 results at 3 sites)
100% agreement for an MSS sample at approximately
125,000 and 500,000 cells/slice
100% agreement for an MSI-H sample at
approximately 125,000 and 500,000 cells/slice
Between Lot Reproducibility
(240 results on 3 lots)
100% agreement for an MSS sample at approximately
125,000 and 500,000 cells/slice
100% agreement for an MSI-H sample at
approximately 125,000 and 500,000 cells/slice
ACCURACY – CLINICAL PERFORMANCE EVALUATION
Overall agreement with Promega MSI Analysis System v1.2 and Immunohistochemistry (IHC) of respectively
99.7% and 97.5%.
99.7% overall concordance with Promega MSI (322/323)
330 CRC samples
Promega MSI Analysis System v1.2
MSI-H MSS Failed
Idylla™ MSI Test
MSI-H 75 0 0
MSS 1(i) 247 5
Invalid 0 0 2
(i) Failed in 1st Promega run; MSI-H in 2nd Promega run, and dMMR with IHC
97.5% overall concordance with IHC (310/318)
330 CRC samples
IHC MMR
dMMR pMMR Doubtful
Idylla™ MSI Test
MSI-H 72 0 3
MSS 8(ii) 238 7
Invalid 0 2 0
(ii) 7 confirmed as MSS by Promega MSI Analysis System v1.2
2
Biocartis and Idylla are registered trademarks in Europe, the United States and other countries. The Biocartis and the Idylla trademarks and logos are
used trademarks owned by Biocartis. Idylla™ platform and Idylla™ MSI Test are CE-marked IVD’s in Europe. Idylla™ is available for sale in EU, USA and
some other countries. Please check availability with the local Biocartis sales representative.
GL.FL028.EN.N.02/2019
RESEARCH APPLICATIONS*
- Nicka CM et al. Detection of Microsatellite Instability in Endometrial Carcinoma Using the Novel Idylla MSI
Assay. Abstract ST127, AMP 2018.
- Maloney NS et al. Biocartis Idylla Cartridge-based Microsatellite Instability Assay Shows High Concordance
with Immunohistochemical Analysis for Mismatch Repair Status in Colorectal Cancer. Abstract TT054, AMP 2018.
- Nafa K et al. Rapid Assessment of Microsatellite Instability Status using the Idylla MSI Test. Abstract ST119, AMP 2018.
- De Craene B et al. Detection of microsatellite instability (MSI) with a novel set of 7 Idylla™ biomarkers on
colorectal cancer samples in a multi-center study. Poster #162P, ESMO 2018.
- De Craene B et al. Detection of microsatellite instability (MSI) in colorectal cancer samples with a novel set of
highly sensitive markers by means of the Idylla MSI Test prototype. Online Abstract #e15639, ASCO 2018.
- 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. Online Abstract #e15654, ASCO 2018.
- De Craene B et al. Detection of microsatellite instability (MSI) with a novel panel of biomarkers in gastric
cancer samples. Poster #697P, ESMO 2017.
- Maertens G et al. Detection of microsatellite instability (MSI) in colorectal cancer samples with the automated
Idylla™ MSI Test. Poster #138P, ESMO 2017.
IDYLLA™ MSI WEBCASTS*
- Dr Elena Guerini Rocco, IEO Milan, ECP MSI Industry Symposium, Sept 11th, 2018 - on-demand webcast;
http://biocartis.hybridwebcast.com/ecp2018/library.
- Bram De Craene, Biocartis Belgium, ECP MSI Industry Symposium, Sept 11th, 2018 - on-demand webcast;
http://biocartis.hybridwebcast.com/ecp2018/library.
- Dr. Sofi e Metsu, HistoGeneX Belgium, ECP MSI Industry Symposium, Sept 11th, 2018 - on-demand webcast;
http://biocartis.hybridwebcast.com/ecp2018/library.
* Studies were performed with Idylla™ MSI prototype or RUO (Research Use Only) cartridges