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Related Experiment Video

Updated: Apr 18, 2026

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The anaplastic lymphoma kinase testing conundrum.

Esther Conde1, Philippe Taniere, Fernando Lopez-Rios

  • 1Laboratorio de Dianas Terapéuticas, Hospital HM Universitario Sanchinarro, Universidad San Pablo-CEU, Faculty of Medicine, C/Oña, 10. 28050 Madrid, Spain.

Expert Review of Molecular Diagnostics
|January 13, 2015
PubMed
Summary

Accurate identification of anaplastic lymphoma kinase (ALK)-positive lung cancer is crucial for effective treatment. Standardized ALK testing assays, including FISH and Immunohistochemistry, are recommended for reliable patient stratification.

Keywords:
ALKFISHIHCcompanion diagnosticslung cancer

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Area of Science:

  • Oncology
  • Molecular Diagnostics
  • Biomarker Discovery

Background:

  • Anaplastic lymphoma kinase (ALK) inhibitors have shown significant efficacy in clinical trials for lung carcinoma.
  • Accurate identification of ALK-positive patients is essential for guiding targeted therapy decisions.
  • There is a growing need for harmonized companion diagnostics for ALK testing.

Discussion:

  • Standardization of ALK testing assays in both analytical (performance) and post-analytical (interpretation) phases is critical.
  • Both Fluorescence In Situ Hybridization (FISH) and Immunohistochemistry (IHC) are viable primary methods for routine ALK testing.
  • Strict adherence to protocols and scoring at least 50 tumor cells are necessary for reliable results with FISH and IHC.

Key Insights:

  • FISH and IHC are recommended for routine ALK testing in lung carcinoma when guidelines are followed.
  • Standardized ALK testing ensures accurate patient selection for ALK inhibitor therapy.
  • Harmonized companion diagnostics are vital for economic, scientific, and medical reasons.

Outlook:

  • Development of standardized ALK testing improves patient outcomes in lung cancer.
  • The demand for studying multiple predictive biomarkers necessitates rapid and reliable testing approaches.
  • Future efforts should focus on further refining and harmonizing diagnostic assays for precision oncology.