ALK Protein Analysis by IHC Staining after Recent Regulatory Changes: A Comparison of Two Widely Used Approaches, Revision of the Literature, and a New.

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ALK Protein Analysis by IHC Staining after Recent Regulatory Changes: A Comparison of Two Widely Used Approaches, Revision of the Literature, and a New Testing Algorithm Antonio Marchetti, MD, PhD, Alessia Di Lorito, MD, Maria Vittoria Pace, BSc, Manuela Iezzi, MD, PhD, Lara Felicioni, PhD, Tommaso D’Antuono, B.Tech., Giampaolo Filice, PhD, Luigi Guetti, MD, Felice Mucilli, MD, Fiamma Buttitta, MD, PhD Journal of Thoracic Oncology Volume 11, Issue 4, Pages 487-495 (April 2016) DOI: 10.1016/j.jtho.2015.12.111 Copyright © 2016 International Association for the Study of Lung Cancer Terms and Conditions

Figure 1 Comparison of fluorescence in situ hybridization (FISH), immunohistochemical assay with the Ventana anti-ALK(D5F3)CDx assay (D5F3), and a standard immunohistochemical assay with the clone 5A4 (Novocastra) (5A4) with their scores on selected cases. NEG, negative; POS, positive. Journal of Thoracic Oncology 2016 11, 487-495DOI: (10.1016/j.jtho.2015.12.111) Copyright © 2016 International Association for the Study of Lung Cancer Terms and Conditions

Figure 2 Comprehensive algorithm for the selection of patients with non–small cell lung cancer to be treated with anti–anaplastic lymphoma receptor tyrosine kinase (ALK) therapy. A first step by immunohistochemical (IHC) staining with a companion diagnostic (CDx) assay based on a binary scoring system or IHC with a laboratory-developed test (LDT) based on a four-level score is suggested. Fluorescence in situ hybridization (FISH) analysis is reserved for cases scored 2+ or 1+ by an LDT assay and for IHC analysis–negative cases with clinicopathological parameters more frequently reported in ALK-positive patients (large green box). Further confirmation by real-time polymerase chain reaction (RT-PCR), next-generation sequencing (NGS), or other non–in situ techniques is recommended in cases scored 2+ by an LDT assay and negative by FISH (small green box). TTF1, thyroid transcription factor 1. Journal of Thoracic Oncology 2016 11, 487-495DOI: (10.1016/j.jtho.2015.12.111) Copyright © 2016 International Association for the Study of Lung Cancer Terms and Conditions