TECHNICAL SHEET IDYLLA™ MSI TEST - Biocartis...TECHNICAL SHEET IDYLLA MSI TEST The Idylla MSI Test...

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