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Oncotarget. 2017 Oct 4;8(61):103055-103062. doi: 10.18632/oncotarget.21476. eCollection 2017 Nov 28.

Optimization of EGFR mutation detection by the fully-automated qPCR-based Idylla system on tumor tissue from patients with non-small cell lung cancer.

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Laboratory of Clinical and Experimental Pathology, Pasteur Hospital, FHU OncoAge, University Côte d'Azur, Nice, France.
IRCAN Inserm U1081/CNRS 7284, FHU OncoAge, University Côte d'Azur, Nice, France.
Hospital-related Biobank (BB-0033-00025), Pasteur Hospital, FHU OncoAge, University Côte d'Azur, Nice, France.
Department of Pathology, Rouen University Hospital, Rouen, France.
Department of Pulmonary Medicine and Thoracic Oncology, Pasteur Hospital, FHU OncoAge, University Côte d'Azur, Nice, France.
Department of Thoracic Surgery, Pasteur Hospital, FHU OncoAge, University Côte d'Azur, Nice, France.


Treatment with EGFR inhibitors is limited to patients with advanced/metastatic non-small cell lung cancer who have known EGFR mutations. Currently, patient care has to respond to several imperatives to make these inhibitors broadly available to all patients; fast and accurate detection of EGFR mutations by a sensitive and specific standardized cost-effective method, easy-to-implement in settings with limited expertise in molecular diagnostics. We evaluated the Idylla™ EGFR Mutation Assay (Biocartis) for the detection of EGFR mutations in archived formalin-fixed paraffin-embedded (FFPE) tumor samples from a series of 55 patients with lung adenocarcinoma and compared these results with those obtained by a pyrosequencing ISO-15189 accredited laboratory method. The comparison was made on both whole surgical tumor sections and on three artificially constructed small biopsies (∼1 mm) from the same FFPE blocks. Cost-effectiveness and turnaround time comparison between the two methods was performed. On both whole tissue sections and on biopsy cores, the Idylla™ and pyrosequencing had an agreement of 95% (52/55). The Idylla™ EGFR Assay produced results faster and more cost-effective than pyrosequencing. The Idylla™ system showed a good sensitivity and was cost-saving in our setting. Because of the easy workflow, the Idylla™ system has the potential to expand EGFR testing to more pathology laboratories in a reliable and fast manner.


EGFR; NSCLC; PCR; optimization; targeted therapy

Conflict of interest statement

CONFLICTS OF INTEREST Paul Hofman is an expert member of the scientific advisory board for Biocartis NV, Mechelen, Belgium. All other authors have declared no conflicts of interest.

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