Comparison of Amplicon-Based Next-Generation Sequencing Testing and Immunohistochemical Staining in…

Cohort studyCancers· Jun 2026

Comparison of Amplicon-Based Next-Generation Sequencing Testing and Immunohistochemical Staining in Detecting Anaplastic Lymphoma Kinase Fusion Genes in Non-Small-Cell Lung Cancer: A Large Single-Centre Cohort Study.

Yuichiro Suzukawa, Yuto Tagawa, Seigo Katakura … Shuji Murakami

Molecular PathologyCohort studyQ1IF 4.9

ALK immunohistochemistry positive predictive value for next-generation sequencing-detected ALK fusion was 85.7%.

Comparison of Amplicon-Based Next-Generation Sequencing Testing and Immunohistochemical Staining in Detecting Anaplastic Lymphoma Kinase Fusion Genes in Non-Small-Cell Lung Cancer: A Large Single-Centre Cohort Study.

Yuichiro Suzukawa … Shuji Murakami

Cancers · Jun 2026

Background

Next-generation sequencing (next-generation sequencing)-based tests are the standard of care for detecting actionable gene alterations; however, false negatives remain a concern.

Methods

A retrospective analysis was conducted on consecutive patients with non-small-cell lung cancer who were tested using the Oncomine Dx Target Test (Oncomine Dx Target Test), an amplicon-based DNA and RNA next-generation sequencing test for non-small-cell lung cancer, and ALK-immunohistochemistry (IHC) at our institution between 8 August 2019 and 11 April 2025.

n = 919 eligible patients

Results

85.7%

IHC-positive cases were truly ALK-fusion positive most of the time

n = 919 eligible patients

More results

Of 919 eligible patients included in this study, ALK fusion was detected in 30 (3.26%) patients, whereas ALK-IHC was positive in 35 (3.80%) patients.

The concordance and κ coefficient of the two tests were 99.4% and 0.920, respectively.

Five discordant patients were next-generation sequencing negative and IHC positive.

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Conclusion · 1 of 2

ALK-IHC shows diagnostic accuracy comparable to Oncomine Dx Target Test, although prudent interpretation is needed for patients without adenocarcinoma.

Conclusion · 2 of 2

Our findings suggest the complementary role of ALK-IHC alongside next-generation sequencing-based testing, particularly in patients with a high pre-test probability of harbouring ALK fusions.

Comparison of Amplicon-Based Next-Generation Sequencing Testing and Immunohistochemical Staining in Detecting Anaplastic Lymphoma Kinase Fusion Genes in Non-Small-Cell Lung Cancer: A Large Single-Centre Cohort Study.

Comparison of Amplicon-Based Next-Generation Sequencing Testing and Immunohistochemical Staining in Detecting Anaplastic Lymphoma Kinase Fusion Genes in Non-Small-Cell Lung Cancer: A Large Single-Centre Cohort Study.

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