The Journal of Molecular Diagnostics: March 2018 (Volume 20, Issue 2)

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	Editorial
	Keeping Practice Recommendations in Step with Advancing Knowledge Barbara Zehnbauer
	Special Article
	Updated Molecular Testing Guideline for the Selection of Lung Cancer Patients for Treatment With Targeted Tyrosine Kinase Inhibitors Neal I. Lindeman, Philip T. Cagle, Dara L. Aisner, Maria E. Arcila, Mary Beth Beasley, Eric H. Bernicker, Carol Colasacco, Sanja Dacic, Fred R. Hirsch, Keith Kerr, David J. Kwiatkowski, Marc Ladanyi, Jan A. Nowak, Lynette Sholl, Robyn Temple-Smolkin, Benjamin Solomon, Lesley H. Souter, Erik Thunnissen, Ming S. Tsao, Christina B. Ventura, Murry W. Wynes, Yasushi Yatabe
	Commentaries
	Perspectives on the Affordability of Precision Medicine Daniel H. Farkas
	Next-Generation Sequencing for Lymphomas Robert S. Ohgami, Andreas Rosenwald, Adam Bagg
	Technical Advance
	SNPitty Job van Riet, Niels M.G. Krol, Peggy N. Atmodimedjo, Erwin Brosens, Wilfred. F.J. van IJcken, Maurice P.H.M. Jansen, John W.M. Martens, Leendert H. Looijenga, Guido Jenster, Hendrikus J. Dubbink, Winand N.M. Dinjens, Harmen J.G. van de Werken
	Regular Articles
	The History and Impact of Molecular Coding Changes on Coverage and Reimbursement of Molecular Diagnostic Tests Susan J. Hsiao, Mahesh M. Mansukhani, Melissa C. Carter, Anthony N. Sireci
	Comprehensive Genomic Profiling of Malignant Effusions in Patients with Metastatic Lung Adenocarcinoma Soo-Ryum Yang, Chieh-Yu Lin, Henning Stehr, Steven R. Long, Christina S. Kong, Gerald J. Berry, James L. Zehnder, Christian A. Kunder
	Conventional and Single-Molecule Targeted Sequencing Method for Specific Variant Detection in IKBKG while Bypassing the IKBKGP1 Pseudogene Glynis Frans, Wim Meert, Jutte Van der Werff Ten Bosch, Isabelle Meyts, Xavier Bossuyt, Joris R. Vermeesch, Matthew S. Hestand
	Assessment of Capture and Amplicon-Based Approaches for the Development of a Targeted Next-Generation Sequencing Pipeline to Personalize Lymphoma Management Stacy S. Hung, Barbara Meissner, Elizabeth A. Chavez, Susana Ben-Neriah, Daisuke Ennishi, Martin R. Jones, Hennady P. Shulha, Fong Chun Chan, Merrill Boyle, Robert Kridel, Randy D. Gascoyne, Andrew J. Mungall, Marco A. Marra, David W. Scott, Joseph M. Connors, Christian Steidl
	Evaluation of a Urine-Based Rapid Molecular Diagnostic Test with Potential to Be Used at Point-of-Care for Pulmonary Tuberculosis Krutarth Patel, Matilde Nagel, Maria Wesolowski, Stefan Dees, Eric Rivera-Milla, Christof Geldmacher, Keertan Dheda, Michael Hoelscher, Ines Labugger
	A Novel and Reliable Method to Detect Microsatellite Instability in Colorectal Cancer by Next-Generation Sequencing Lizhen Zhu, Yanqin Huang, Xuefeng Fang, Chenglin Liu, Wanglong Deng, Chenhan Zhong, Jinghong Xu, Dong Xu, Ying Yuan
	Evaluation of Diagnostic Utility of a High-Risk Human Papillomavirus PCR Test on Formalin-Fixed, Paraffin-Embedded Head and Neck Tumor Tissues Albert N. Huho, Nour Yadak, Thèrése J. Bocklage, Shangxin Yang
	Droplet Digital PCR for Mutation Detection in Formalin-Fixed, Paraffin-Embedded Melanoma Tissues Ashleigh C. McEvoy, Benjamin A. Wood, Nima M. Ardakani, Michelle R. Pereira, Robert Pearce, Lester Cowell, Cleo Robinson, Fabienne Grieu-Iacopetta, Alexander J. Spicer, Benhur Amanuel, Melanie Ziman, Elin S. Gray
	Evaluation of a Pan-Leishmania Spliced-Leader RNA Detection Method in Human Blood and Experimentally Infected Syrian Golden Hamsters Eline Eberhardt, Magali Van den Kerkhof, Dimitri Bulté, Dorien Mabille, Lieselotte Van Bockstal, Séverine Monnerat, Fabiana Alves, Jane Mbui, Peter Delputte, Paul Cos, Sarah Hendrickx, Louis Maes, Guy Caljon
	Correspondence
	MYD88 Mutations and Sensitivity to Ibrutinib Therapy Y. Lynn Wang
	Authors’ Reply Victor Bobée, Philippe Ruminy, Vinciane Marchand, Pierre-Julien Viailly, Ahmad Abdel Sater, Liana Veresezan, Fanny Drieux, Caroline Bérard, Elodie Bohers, Sylvain Mareschal, Sydney Dubois, Jean-Philippe Jais, Karen Leroy, Martin Figeac, Jean-Michel Picquenot, Thierry J. Molina, Gilles Salles, Corinne Haioun, Hervé Tilly, Fabrice Jardin

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Evaluation of Diagnostic Utility of a High-Risk Human Papillomavirus PCR Test on Formalin-Fixed, Paraffin-Embedded Head and Neck Tumor Tissues
Albert N. Huho, Nour Yadak, Thèrése J. Bocklage, Shangxin Yang'Correspondence information about the author Shangxin YangEmail the author Shangxin Yang

The increasing prevalence of high-risk human papillomavirus (HR-HPV)–associated head and neck squamous cell carcinoma (HNSCC) has prompted strong clinical demands for detecting HR-HPV directly in the tumor. Although p16 immunohistochemistry (IHC) has been the standard testing method, it has limitations including false positivity, lack of sensitivity in low tumor cell samples such as fine-needle aspirate (FNA), and its subjectivity. We developed a modified method based on a commercial automated HR-HPV PCR assay and evaluated the performance characteristics and the diagnostic utility of this assay for direct HR-HPV detection in the HNSCC samples. HNSCC formalin-fixed, paraffin-embedded blocks were retrieved from archives including 44 excisions, 63 biopsies, and 16 FNAs. Tissue slices were trimmed from the blocks, deparaffinized, lysed, and loaded on the commercial automated platform for HR-HPV PCR. All specimens had a concurrent p16 IHC performed. The PCR assay showed high concordance with the p16 IHC (96%; 99/103) and excellent positive agreement (91.5%) and negative agreement (100%). In addition, the PCR assay provided more conclusive results in samples with equivocal p16 IHC results. The modified commercial automated HR-HPV PCR test is a labor-efficient, quick, reliable, sensitive, and specific method for detecting HR-HPV in formalin-fixed, paraffin-embedded samples. This assay also showed excellent diagnostic utility in samples with equivocal p16 IHC results, including FNA cell blocks.