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ORIGINAL ARTICLE New Methods for ALK Status Diagnosis in Non–Small-Cell Lung Cancer An Improved ALK Immunohistochemical Assay and a New, Brightfield, Dual ALK IHC–In Situ Hybridization Assay Hiroaki Nitta, PhD, MBA,* Koji Tsuta, MD, PhD,† Akihiko Yoshida, MD, PhD,† Steffan N. Ho, MD, PhD,‡ Brian D. Kelly, PhD,* Lauren B. Murata, PhD,* Jerry Kosmeder, PhD,* Katie White, PhD,* Sandra Ehser, PhD,§ Penny Towne, MBA,* Crystal Schemp, MPH,* Abigail McElhinny, PhD,* Jim Ranger-Moore, PhD,* Chris Bieniarz, PhD,* Shalini Singh, MD,* Hitoshi Tsuda, MD, PhD,† and Thomas M. Grogan, MD* was similar in ALK detection sensitivity to the HQ-tyramide IHC sys- Introduction: The demonstration of anaplastic lymphoma kinase tem and was compatible with the brightfield in situ hybridization assay. (ALK) positivity in non–small-cell lung cancer (NSCLC) has been Conclusion: The new HQ-tyramide IHC reagent system allows more hindered by the technical complexity and interpretative challenges of sensitive assessment of ALK protein status in NSCLC cases. The new fluorescence in situ hybridization methods for detection of ALK gene ALK gene-protein assay allows the concurrent visualization of ALK rearrangement and by the inadequate sensitivity of existing immu- gene and ALK protein status in single cells, allowing more accurate nohistochemistry (IHC) methods for ALK protein detection. In this ALK status determination even
Journal of Thoracic Oncology – Wolters Kluwer Health
Published: Aug 1, 2013
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