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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 area 50–600 mm² (5 µm) 25-300 mm² (10 µm) MSI 1 CE IVD

TECHNICAL SHEET IDYLLA™ MSI TEST - Biocartis...TECHNICAL SHEET IDYLLA MSI TEST The Idylla MSI Test is intended for the qualitative detection of a novel panel of seven monomorphic

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Page 1: TECHNICAL SHEET IDYLLA™ MSI TEST - Biocartis...TECHNICAL SHEET IDYLLA MSI TEST The Idylla MSI Test is intended for the qualitative detection of a novel panel of seven monomorphic

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

Page 2: TECHNICAL SHEET IDYLLA™ MSI TEST - Biocartis...TECHNICAL SHEET IDYLLA MSI TEST The Idylla MSI Test is intended for the qualitative detection of a novel panel of seven monomorphic

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

Page 3: TECHNICAL SHEET IDYLLA™ MSI TEST - Biocartis...TECHNICAL SHEET IDYLLA MSI TEST The Idylla MSI Test is intended for the qualitative detection of a novel panel of seven monomorphic

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