Comparison of next-generation sequencing and cobas EGFR mutation test v2 in detecting EGFR mutations.

cobas EGFR mutation test v2 epidermal growth factor receptor gene (EGFR) mutation next-generation sequencing non-small cell lung cancer oncomine dx target test

Journal

Thoracic cancer
ISSN: 1759-7714
Titre abrégé: Thorac Cancer
Pays: Singapore
ID NLM: 101531441

Informations de publication

Date de publication:
11 2022
Historique:
revised: 22 09 2022
received: 16 08 2022
accepted: 23 09 2022
pubmed: 7 10 2022
medline: 18 11 2022
entrez: 6 10 2022
Statut: ppublish

Résumé

As the number of genetic mutations that must be tested increases, the Oncomine Dx Target test (ODxTT), which can simultaneously detect multiple cancer-related genes is becoming the main test used in preference to single-molecule testing. In this study, we evaluated the performance of ODxTT and cobas EGFR mutation test v2 (cobas EGFR), one of the single-molecule tests, in detecting EGFR mutations. Samples from 211 patients diagnosed with NS-NSCLC were tested simultaneously or sequentially with the cobas EGFR mutation test and ODxTT. We compared the success and detection rates of both tests and evaluated their equivalence by determining the concordance rate and k-coefficient of both tests. The success rate in detecting EGFR mutations was 95.7% for ODxTT and 100% for cobas EGFR. EGFR mutations were detected in 26.5% of samples with ODxTT and in 28.0% with cobas EGFR. For the 200 samples successfully analyzed with both tests, the concordance rate and k-coefficient were 97.5% and 0.938, respectively. ODxTT failed to detect two exon 19 deletion mutations (p.E746_P753delinsVS and p.E746_P753delinsLS), and cobas EGFR failed to detect three instances of an exon 19 deletion (p.L747_P753delinsS), L861R, and an exon 20 insertion. The success rate of ODxTT is slightly inferior to that of cobas EGFR. ODxTT shared a high concordance rate and k-coefficient with cobas EGFR in detecting EGFR mutations, but discordant results between the two tests were observed in a few cases, mainly due to the difference of detectable EGFR variants.

Sections du résumé

BACKGROUND
As the number of genetic mutations that must be tested increases, the Oncomine Dx Target test (ODxTT), which can simultaneously detect multiple cancer-related genes is becoming the main test used in preference to single-molecule testing. In this study, we evaluated the performance of ODxTT and cobas EGFR mutation test v2 (cobas EGFR), one of the single-molecule tests, in detecting EGFR mutations.
METHODS
Samples from 211 patients diagnosed with NS-NSCLC were tested simultaneously or sequentially with the cobas EGFR mutation test and ODxTT. We compared the success and detection rates of both tests and evaluated their equivalence by determining the concordance rate and k-coefficient of both tests.
RESULTS
The success rate in detecting EGFR mutations was 95.7% for ODxTT and 100% for cobas EGFR. EGFR mutations were detected in 26.5% of samples with ODxTT and in 28.0% with cobas EGFR. For the 200 samples successfully analyzed with both tests, the concordance rate and k-coefficient were 97.5% and 0.938, respectively. ODxTT failed to detect two exon 19 deletion mutations (p.E746_P753delinsVS and p.E746_P753delinsLS), and cobas EGFR failed to detect three instances of an exon 19 deletion (p.L747_P753delinsS), L861R, and an exon 20 insertion.
DISCUSSION
The success rate of ODxTT is slightly inferior to that of cobas EGFR. ODxTT shared a high concordance rate and k-coefficient with cobas EGFR in detecting EGFR mutations, but discordant results between the two tests were observed in a few cases, mainly due to the difference of detectable EGFR variants.

Identifiants

pubmed: 36203199
doi: 10.1111/1759-7714.14685
pmc: PMC9663664
doi:

Substances chimiques

ErbB Receptors EC 2.7.10.1
EGFR protein, human EC 2.7.10.1

Types de publication

Journal Article Research Support, Non-U.S. Gov't

Langues

eng

Sous-ensembles de citation

IM

Pagination

3217-3224

Informations de copyright

© 2022 The Authors. Thoracic Cancer published by China Lung Oncology Group and John Wiley & Sons Australia, Ltd.

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Auteurs

Shuji Murakami (S)

Department of Thoracic Oncology, Kanagawa Cancer Center, Yokohama, Japan.

Tomoyuki Yokose (T)

Department of Pathology, Kanagawa Cancer Center, Yokohama, Japan.

Kanako Shinada (K)

Department of Thoracic Oncology, Kanagawa Cancer Center, Yokohama, Japan.

Testuya Isaka (T)

Department of Thoracic Oncology, Kanagawa Cancer Center, Yokohama, Japan.

Kengo Katakura (K)

Department of Thoracic Oncology, Kanagawa Cancer Center, Yokohama, Japan.

Ryouta Ushio (R)

Department of Thoracic Oncology, Kanagawa Cancer Center, Yokohama, Japan.

Tetsuro Kondo (T)

Department of Thoracic Oncology, Kanagawa Cancer Center, Yokohama, Japan.

Terufumi Kato (T)

Department of Thoracic Oncology, Kanagawa Cancer Center, Yokohama, Japan.

Hiroyuki Ito (H)

Department of Thoracic Oncology, Kanagawa Cancer Center, Yokohama, Japan.

Haruhiro Saito (H)

Department of Thoracic Oncology, Kanagawa Cancer Center, Yokohama, Japan.

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