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Association for Molecular Pathology

Molecular Testing Guideline for Selection of Lung Cancer Patients for EGFR and ALK Tyrosine Kinase Inhibitors

Lung Biomarker Guideline Released April 2013 by CAP, IASLC, and AMP

Revised Guidline in development for publication in early 2016.



The College of American Pathologists (CAP), the International Association for the Study of Lung Cancer (IASLC), and the Association for Molecular Pathology (AMP) have released a new evidence-based guideline:

Molecular Testing Guideline for the Selection of Lung Cancer Patients for EGFR and ALK Tyrosine Kinase Inhibitors

Published first online in the May 2013 issue of The Journal of Molecular Diagnostics, the guideline was developed to establish standards for testing for EGFR and ALK, helping to guide targeted therapies. The key recommendation in the guideline is that doctors should order EGFR mutation and ALK rearrangement testing at the time of diagnosis for patients who present with advanced lung cancer, regardless of their clinical history. The guideline answers important clinical questions, including:

o When should testing be performed?
o How should testing be performed?
o Should other genes be routinely tested in lung cancer?
o How should molecular testing of lung cancer be implemented?

In addition, the guideline encourages EGFR and ALK testing of tumors at diagnosis from patients presenting with stage I, II, or III disease or, if testing is not to be performed in early stages, that tissue be reserved for future analysis if the patient progresses to advanced stage.

Pathologists are encouraged to implement the new guideline at their institutions and into their practices to help improve the effectiveness of lung cancer treatment. The release of the guideline is timely because testing for EGFR and ALK have transitioned to standard of care for many patients. The guideline will be updated as appropriate and guidelines for other biomarkers associated with lung cancer will be added as evidence-based research becomes available.