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ORIGINAL ARTICLE An International Interpretation Study Using the ALK IHC Antibody D5F3 and a Sensitive Detection Kit Demonstrates High Concordance between ALK IHC and ALK FISH and between Evaluators Murry W. Wynes, PhD,* Lynette M. Sholl, MD,† Manfred Dietel, MD,‡ Ed Schuuring, PhD,§ Ming S. Tsao, MD, FRCPC,‖ Yasushi Yatabe, ME, PhD,¶ Raymond R. Tubbs, DO,# and Fred R. Hirsch, MD, PhD***†† score. IHC negativity was scored by seven of seven and six of seven Introduction: The goal of personalized medicine is to treat patients evaluators on three and two FISH-positive cases, respectively. IHC with a therapy predicted to be efficacious based on the molecular positivity was scored on two FISH-negative cases by seven of seven characteristics of the tumor, thereby sparing the patient futile or toxic readers. There was agreement among seven of seven and six of seven therapy. Anaplastic lymphoma kinase (ALK) inhibitors are effective readers on 88% and 96% of the cases before review, respectively, and against ALK-positive non–small-cell lung cancer (NSCLC) tumors, after review there was agreement among seven of seven and six of but to date the only approved companion diagnostic is a break-apart seven on 95% and 97% of the cases, respectively. fluorescence in situ hybridization (FISH) assay. Immunohistochemistry Conclusions: On the basis of expert evaluation the ALK IHC test (IHC) is a clinically applicable cost-effective
Journal of Thoracic Oncology – Wolters Kluwer Health
Published: May 1, 2014
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