Performance of Ultra-Rapid Idylla™ EGFR Mutation Test in Non-Small-Cell Lung Cancer and Its Potential at Clinical Molecular Screening

Author:

Suda Kenichi1ORCID,Sakai Kazuko2,Ohira Tatsuo3,Chikugo Takaaki4,Satou Takao4,Matsubayashi Jun5,Nagao Toshitaka5ORCID,Ikeda Norihiko3,Tsutani Yasuhiro1ORCID,Mitsudomi Tetsuya1,Nishio Kazuto2ORCID

Affiliation:

1. Division of Thoracic Surgery, Department of Surgery, Kindai University Faculty of Medicine, Osakasayama 589-8511, Japan

2. Department of Genome Biology, Kindai University Faculty of Medicine, Osakasayama 589-8511, Japan

3. Department of Surgery, Tokyo Medical University, Shinjuku-ku, Tokyo 160-0023, Japan

4. Department of Diagnostic Pathology, Kindai University Hospital, Osakasayama 589-8511, Japan

5. Department of Anatomic Pathology, Tokyo Medical University, Shinjuku-ku, Tokyo 160-0023, Japan

Abstract

Background: The Idylla™ EGFR Mutation Test is an ultra-rapid single-gene test that detects epidermal growth factor receptor (EGFR) mutations using formalin-fixed paraffin-embedded specimens. Here, we compared the performance of the Idylla EGFR Mutation Test with the Cobas® EGFR Mutation Test v2. Methods: Surgically resected NSCLC specimens obtained at two Japanese institutions (N = 170) were examined. The Idylla EGFR Mutation Test and the Cobas EGFR Mutation Test v2 were performed independently and the results were compared. For discordant cases, the Ion AmpliSeq Colon and Lung Cancer Research Panel V2 was performed. Results: After the exclusion of five inadequate/invalid samples, 165 cases were evaluated. EGFR mutation analysis revealed 52 were positive and 107 were negative for EGFR mutation in both assays (overall concordance rate: 96.4%). Analyses of the six discordant cases revealed that the Idylla EGFR Mutation Test was correct in four and the Cobas EGFR Mutation Test v2 was correct in two. In a trial calculation, the combination of the Idylla EGFR Mutation Test followed by a multi-gene panel test will reduce molecular screening expenses if applied to a cohort with EGFR mutation frequency >17.9%. Conclusions: We demonstrated the accuracy and potential clinical utility of the Idylla EGFR Mutation Test as a molecular screening platform in terms of turnaround time and molecular testing cost if applied to a cohort with a high EGFR mutation incidence (>17.9%).

Funder

Nichirei Bioscience Inc.

Japan Society for the Promotion of Science

Publisher

MDPI AG

Subject

Cancer Research,Oncology

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