Abstract
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.
Highlights
The detection of EGFR activating or resistance mutations associated with advanced or metastatic nonsmall cell lung cancer (NSCLC) allows targeted treatment with first, second- or third-generation tyrosine kinase inhibitors [1, 2]
We evaluated the IdyllaTM 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
IdyllaTM detected the EGFR mutation observed by the reference method, as well as a supplementary mutation L861Q on exon 21 and T790M mutation on exon 20 not detected by the reference assay (Cases 1 and 25, Supplementary Table 1)
Summary
The detection of EGFR activating or resistance mutations associated with advanced or metastatic nonsmall cell lung cancer (NSCLC) allows targeted treatment with first-, second- or third-generation tyrosine kinase inhibitors [1, 2]. There are many molecular biological methods deployed for detection of EGFR activating or resistance mutations but with various and different sensitivity [7,8,9] These methods have variable cost, and results turn-around time depends on their complexity and the sample flow. The aim of this study is to analyze benefits and disadvantages of the IdyllaTM system for the detection of EGFR mutations in a series of 18 NSCLC patients whose mutated status was already known by pyrosequencing, which is our reference method in the laboratory, and accredited according to the ISO 15189 standard (http://www.cofrac.fr/en/organismes/fiche.php?entite_ id=82017619) This comparison focusses on sensitivity, turnaround time, and cost of both methods used (IdyllaTM versus pyrosequencing)
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