A Screening Method for the ALK Fusion Gene in NSCLC
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Updated: May 21, 2026
Oncogenic Gene Fusion Detection Using Anchored Multiplex Polymerase Chain Reaction Followed by Next Generation Sequencing
Published on: July 5, 2019
Yoshiko Murakami1, Tetsuya Mitsudomi, Yasushi Yatabe
1Department of Pathology and Molecular Diagnostics, Aichi Cancer Center Nagoya, Japan.
Abstract:
Lung cancer research has recently made significant progress in understanding the molecular pathogenesis of lung cancer and in developing treatments for it. Such achievements are directly utilized in clinical practice. Indeed, the echinoderm microtubule-associated protein-like 4-anaplastic lymphoma kinase (ALK) fusion gene was first described in non-small cell lung cancer in 2007, and a molecularly targeted drug against the fusion was approved in 2011. However, lung cancer with the ALK fusion constitutes only a small fraction of lung cancers; therefore, efficient patient selection is crucial for successful treatment using the ALK inhibitor. Currently, RT-PCR, fluorescent in situ hybridization (FISH), and immunohistochemistry are commonly used to detect the ALK fusion. Although FISH is currently the gold standard technique, there are no perfect methods for detecting these genetic alterations. In this article, we discuss the advantages and disadvantages of each method and the possible criteria for selecting patients who are more likely to have the ALK fusion. If we can successfully screen patients, then ALK inhibitor treatment will be the best example of personalized therapy in terms of selecting patients with an uncommon genotype from a larger group with the same tumor phenotype. In other words, the personalized therapy may offer a new challenge for current clinical oncology.
Insights
Identifying echinoderm microtubule-associated protein-like 4-anaplastic lymphoma kinase (ALK) fusions in lung cancer is key for targeted therapy. This review compares methods for detecting ALK fusions to improve patient selection for ALK inhibitors.
Area of Science:
- Oncology
- Molecular Biology
- Genetics
Background:
- Significant advancements in lung cancer molecular pathogenesis and treatment have emerged.
- The echinoderm microtubule-associated protein-like 4-anaplastic lymphoma kinase (ALK) fusion gene, identified in non-small cell lung cancer (NSCLC) in 2007, led to targeted drug approval in 2011.
- ALK-fusion positive lung cancer represents a small subset, necessitating precise patient selection for ALK inhibitor efficacy.
Purpose of the Study:
- To review and compare current methods for detecting ALK fusions in lung cancer.
- To discuss the advantages and disadvantages of RT-PCR, FISH, and IHC for ALK fusion detection.
- To explore criteria for selecting patients most likely to harbor ALK fusions.
Main Methods:
- Review of existing literature on ALK fusion detection techniques in lung cancer.
- Comparative analysis of RT-PCR, fluorescent in situ hybridization (FISH), and immunohistochemistry (IHC).
- Discussion of patient selection strategies for ALK inhibitor therapy.
Main Results:
- FISH is considered the gold standard but no single method is perfect for detecting ALK genetic alterations.
- Each method (RT-PCR, FISH, IHC) presents unique advantages and limitations.
- Effective patient screening is critical for successful ALK inhibitor treatment.
Conclusions:
- Optimizing patient selection for ALK inhibitors exemplifies personalized therapy in oncology.
- Accurate detection of ALK fusions is crucial for realizing the potential of targeted lung cancer treatments.
- Personalized therapy based on molecular profiling presents new challenges and opportunities in clinical oncology.
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