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Assessment of a new ROS1 immunohistochemistry clone (SP384) for the identification of ROS1 rearrangements in patients with non-small cell lung carcinoma: the ROSING study

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dc.contributor.author Conde, Esther
dc.contributor.author Pijuan Andujar, Lara
dc.contributor.author Salido Galeote, Marta
dc.contributor.author Arriola Aperribay, Edurne
dc.contributor.author Company, Amparo
dc.contributor.author Lopez-Rios, Fernando
dc.date.accessioned 2020-02-28T08:43:58Z
dc.date.available 2020-02-28T08:43:58Z
dc.date.issued 2019
dc.identifier.citation Conde E, Hernandez S, Martinez R, Angulo B, De Castro J, Collazo-Lorduy A. et al. Assessment of a new ROS1 immunohistochemistry clone (SP384) for the identification of ROS1 rearrangements in patients with non-small cell lung carcinoma: the ROSING study. J Thorac Oncol. 2019 Dec; 14(12):2120-32. DOI: 10.1016/j.jtho.2019.07.005
dc.identifier.issn 1556-0864
dc.identifier.uri http://hdl.handle.net/10230/43739
dc.description.abstract Introduction: 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.
dc.format.mimetype application/pdf
dc.language.iso eng
dc.publisher Elsevier
dc.rights c) 2019 International Association for the Study of Lung Cancer.Published by Elsevier Inc. This is an open access article under theCC BY-NC-ND license (http://creativecommons.org/licenses/by-nc-nd/4.0/).ISSN: 1556-0864. https://doi.org/10.1016/j.jtho.2019.07.005 Journal of Thoracic Oncology Vol. 14 No. 12: 2120-32
dc.rights.uri http://creativecommons.org/licenses/by-nc-nd/4.0/
dc.title Assessment of a new ROS1 immunohistochemistry clone (SP384) for the identification of ROS1 rearrangements in patients with non-small cell lung carcinoma: the ROSING study
dc.type info:eu-repo/semantics/article
dc.identifier.doi http://dx.doi.org/10.1016/j.jtho.2019.07.005
dc.subject.keyword FISH
dc.subject.keyword Immunohistochemistry
dc.subject.keyword Lung carcinoma
dc.subject.keyword Next-generation sequencing
dc.subject.keyword ROS1
dc.rights.accessRights info:eu-repo/semantics/openAccess
dc.type.version info:eu-repo/semantics/publishedVersion

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