Table 1

Overview of studies on Idylla performance analysis testing

ReferenceYearType of cancerInputGeneSamples (n)ComparisonConcordanceIdylla cartridge
Janku et al 2 2015CRC, melanoma and othersFFPE tissue BRAF 60Real-time PCR;
NGS		97% (real-time PCR);
100% (NGS)		Idylla BRAF mutation test
100PCR-based method; mass spectrometry; NGS96%Idylla BRAF mutation test
Melchior et al 3 2015MelanomaFFPE tissue BRAF 139Real-time PCR; Sanger or pyrosequencing97.84%Idylla BRAF mutation test
Colling et al 4 2016CRCFFPE tissue BRAF 100Real-time PCR98.97%Idylla BRAF mutation test
Janku et al 5 2016CRC, melanoma and othersCell-free DNA vs FFPE BRAF 160PCR-based method; mass spectrometry; NGS88%Idylla BRAF mutation test
Schiefer et al 6 2016Melanoma, papillary thyroid cancer and othersFFPE tissue BRAF 419Sanger or pyrosequencing96.2%–97.5%Idylla BRAF mutation test
Yeo et al 7 2016Papillary thyroid cancer and nodular hyperplasiaFFPE tissue BRAF 110Peptide nucleic acid clamping; real-time PCR; pyrosequencing0.974 (Cohen’s kappa)Idylla BRAF mutation test
De Luca et al 8 2016NSCLCCytological samples EGFR 74(Real-time) PCR100%Idylla EGFR mutation assay
de Biase et al 9 2016Pancreatic cancerCytological samples KRAS 52NGS; Sanger sequencing; allele-specific locked nucleic acid PCRUndisclosedIdylla KRAS mutation test
Solassol et al 10 2016CRCFFPE KRAS 374Sanger sequencing; ddPCR; HRM; pyrosequencing; NGS; real-time PCR; others98.9% (overall)Idylla KRAS mutation assay
Harlé et al 11 2016MelanomaFFPE BRAF 59HRM, real-time PCR, NGS, IHCUndisclosedIdylla BRAF mutation test
Bisschop et al 12 2017MelanomaFFPE tissue BRAF 37HRM; Sanger sequencing; IHC; NGS97.3% (overall)Idylla BRAF mutation test
Barel et al 13 2017MelanomaFFPE BRAF/NRAS 36NGS; IHC97.2% (overall)Idylla NRAS-BRAF-EGFRS492R mutation assay
Johnston et al 14 2018CRCFFPE tissue BRAF/NRAS 242Mass spectrometry99.59% (NRAS);
100% (BRAF)		Idylla NRAS-BRAF mutation test
Colling et al 15 2017CRCFFPE tissue BRAF/NRAS/KRAS 43NGS; IHCBRAF: 90% (IHC), BRAF: 100% (NGS); KRAS: 100% (NGS); NRAS: 100% (NGS)Idylla NRAS-BRAF-EGFR492R mutation assay;
Idylla KRAS mutation test
Ilie et al 16 2017Lung adenocarcinomaFFPE tissue EGFR 55Pyrosequencing95%Idylla EGFR mutation assay
Lambros et al 17 2017NSCLCFFPE tissue EGFR/ KRAS 18ddPCR; NGSUndisclosedIdylla EGFR and KRAS mutation assays
Thomas De Montpréville et al 18 2017NSCLCFFPE and fresh samples EGFR/ KRAS 93NGSUndisclosedIdylla EGFR and KRAS mutation tests
Weyn et al 19 2017mCRCFFPE tissue KRAS 182Real-time PCR96.7%Idylla KRAS mutation test
De Luca et al 20 2017Pancreatic cancer and mCRCCytological samples KRAS 18Real-time PCR100%Idylla KRAS mutation test
Sherwood et al 21 2017NSCLCKRAS-mutant cell lines KRAS N/A12 distinct techniquesN/AIdylla KRAS mutation test
Harle et al 22 2018MelanomaFFPE tissue BRAF 37Real-time PCRUndisclosedIdylla BRAF mutation assay
Prieto-Potin et al 23 2018mCRCFFPE tissue BRAF/NRAS 418NGS; mass spectrometry; Sanger sequencing; pyrosequencing; ddPCR99.51% (BRAF overall)
99.27% (NRAS overall)		Idylla NRAS-BRAF mutation test
De Luca et al 24 2018NSCLCCytological samples EGFR 68NGS100%Idylla EGFR mutation test
Ghigna et al 25 2018NSCLCFFPE EGFR/ KRAS 43NGS; Sanger sequencingUndisclosedIdylla EGFR and KRAS mutation tests

  • CRC, colorectal carcinoma; ddPCR, digital droplet PCR; FFPE, formalin-fixed paraffin-embedded; HRM, high-resolution melting; IHC, immunohistochemistry; mCRC, metastatic colorectal cancer; N/A, not applicable; NGS, next-generation sequencing; NSCLC, non-small cell lung cancer.