000099298 001__ 99298 000099298 005__ 20210223204725.0 000099298 0247_ $$2doi$$a10.1016/j.jtho.2019.07.005 000099298 0248_ $$2sideral$$a122813 000099298 037__ $$aART-2019-122813 000099298 041__ $$aeng 000099298 100__ $$aConde, E. 000099298 245__ $$aAssessment of a New ROS1 Immunohistochemistry Clone (SP384) for the Identification of ROS1 Rearrangements in Patients with Non–Small Cell Lung Carcinoma: the ROSING Study 000099298 260__ $$c2019 000099298 5060_ $$aAccess copy available to the general public$$fUnrestricted 000099298 5203_ $$aIntroduction: The ROS1 gene rearrangement has become an important biomarker in NSCLC. The College of American Pathologists/International Association for the Study of Lung Cancer/Association for Molecular Pathology testing guidelines support the use of ROS1 immunohistochemistry (IHC) as a screening test, followed by confirmation with fluorescence in situ hybridization (FISH) or a molecular test in all positive results. We have evaluated a novel anti-ROS1 IHC antibody (SP384) in a large multicenter series to obtain real-world data. Methods: A total of 43 ROS1 FISH–positive and 193 ROS1 FISH–negative NSCLC samples were studied. All specimens were screened by using two antibodies (clone D4D6 from Cell Signaling Technology and clone SP384 from Ventana Medical Systems), and the different interpretation criteria were compared with break-apart FISH (Vysis). FISH-positive samples were also analyzed with next-generation sequencing (Oncomine Dx Target Test Panel, Thermo Fisher Scientific). Results: An H-score of 150 or higher or the presence of at least 70% of tumor cells with an intensity of staining of 2+ or higher by the SP384 clone was the optimal cutoff value (both with 93% sensitivity and 100% specificity). The D4D6 clone showed similar results, with an H-score of at least 100 (91% sensitivity and 100% specificity). ROS1 expression in normal lung was more frequent with use of the SP384 clone (p < 0.0001). The ezrin gene (EZR)-ROS1 variant was associated with membranous staining and an isolated green signal FISH pattern (p = 0.001 and p = 0.017, respectively). Conclusions: The new SP384 ROS1 IHC clone showed excellent sensitivity without compromising specificity, so it is another excellent analytical option for the proposed testing algorithm. 000099298 536__ $$9info:eu-repo/grantAgreement/ES/ISCIII-FEDER/PI14-0117$$9info:eu-repo/grantAgreement/ES/ISCIII-FEDER/PI17-01001$$9info:eu-repo/grantAgreement/ES/ISCIII-FEDER/PI18-00382$$9info:eu-repo/grantAgreement/ES/ISCIII-FEDER/PT17-0015-0006 000099298 540__ $$9info:eu-repo/semantics/openAccess$$aAll rights reserved$$uhttp://www.europeana.eu/rights/rr-f/ 000099298 590__ $$a13.357$$b2019 000099298 591__ $$aRESPIRATORY SYSTEM$$b3 / 64 = 0.047$$c2019$$dQ1$$eT1 000099298 591__ $$aONCOLOGY$$b11 / 244 = 0.045$$c2019$$dQ1$$eT1 000099298 592__ $$a3.218$$b2019 000099298 593__ $$aMedicine (miscellaneous)$$c2019$$dQ1 000099298 593__ $$aPulmonary and Respiratory Medicine$$c2019$$dQ1 000099298 593__ $$aOncology$$c2019$$dQ1 000099298 655_4 $$ainfo:eu-repo/semantics/article$$vinfo:eu-repo/semantics/acceptedVersion 000099298 700__ $$aHernandez, S. 000099298 700__ $$aMartinez, R. 000099298 700__ $$aAngulo, B. 000099298 700__ $$aDe Castro, J. 000099298 700__ $$aCollazo-Lorduy, A. 000099298 700__ $$aJimenez, B. 000099298 700__ $$aMuriel, A. 000099298 700__ $$aMate, J.L. 000099298 700__ $$aMoran, T. 000099298 700__ $$aAranda, I. 000099298 700__ $$aMassuti, B. 000099298 700__ $$aRojo, F. 000099298 700__ $$aDomine, M. 000099298 700__ $$aSansano, I. 000099298 700__ $$aGarcia, F. 000099298 700__ $$aFelip, E. 000099298 700__ $$aMancheño, N. 000099298 700__ $$aJuan, O. 000099298 700__ $$aSanz, J. 000099298 700__ $$aGonzalez-Larriba, J.L. 000099298 700__ $$aAtienza-Cuevas, L. 000099298 700__ $$aArriola-Arellano, E. 000099298 700__ $$aAbdulkader, I. 000099298 700__ $$aGarcia-Gonzalez, J. 000099298 700__ $$aCamacho, C. 000099298 700__ $$aRodriguez-Abreu, D. 000099298 700__ $$aTeixido, C. 000099298 700__ $$aReguart, N. 000099298 700__ $$aGonzalez-Piñeiro, A. 000099298 700__ $$aLazaro-Quintela, M. 000099298 700__ $$aLozano, M.D. 000099298 700__ $$aGurpide, A. 000099298 700__ $$aGomez-Roman, J. 000099298 700__ $$aLopez-Brea, M. 000099298 700__ $$aPijuan, L. 000099298 700__ $$aSalido, M. 000099298 700__ $$aArriola, E. 000099298 700__ $$aCompany, A. 000099298 700__ $$aInsa, A. 000099298 700__ $$aEsteban-Rodriguez, I. 000099298 700__ $$aSaiz, M. 000099298 700__ $$aAzkona, E. 000099298 700__ $$0(orcid)0000-0003-1038-8152$$aAlvarez, R.$$uUniversidad de Zaragoza 000099298 700__ $$0(orcid)0000-0002-3662-7660$$aArtal, A.$$uUniversidad de Zaragoza 000099298 700__ $$aPlaza, M.L. 000099298 700__ $$aAguiar, D. 000099298 700__ $$aEnguita, A.B. 000099298 700__ $$aBenito, A. 000099298 700__ $$aPaz-Ares, L. 000099298 700__ $$aGarrido, P. 000099298 700__ $$aLopez-Rios, F. 000099298 7102_ $$11003$$2027$$aUniversidad de Zaragoza$$bDpto. Anatom.Histolog.Humanas$$cArea Anatom.Embriol.Humana 000099298 7102_ $$11007$$2610$$aUniversidad de Zaragoza$$bDpto. Medicina, Psiqu. y Derm.$$cArea Medicina 000099298 773__ $$g14, 12 (2019), 2120-2132$$pJ. Thorac. Oncol.$$tJOURNAL OF THORACIC ONCOLOGY$$x1556-0864 000099298 8564_ $$s971833$$uhttps://zaguan.unizar.es/record/99298/files/texto_completo.pdf$$yPostprint 000099298 8564_ $$s1455747$$uhttps://zaguan.unizar.es/record/99298/files/texto_completo.jpg?subformat=icon$$xicon$$yPostprint 000099298 909CO $$ooai:zaguan.unizar.es:99298$$particulos$$pdriver 000099298 951__ $$a2021-02-23-19:03:00 000099298 980__ $$aARTICLE