RT Journal Article T1 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. A1 Conde, Esther A1 Hernandez, Susana A1 Martinez, Rebeca A1 Angulo, Barbara A1 De Castro, Javier A1 Collazo-Lorduy, Ana A1 Jimenez, Beatriz A1 Muriel, Alfonso A1 Mate, Jose Luis A1 Moran, Teresa A1 Aranda, Ignacio A1 Massuti, Bartomeu A1 Rojo, Federico A1 Domine, Manuel A1 Sansano, Irene A1 Garcia, Felip A1 Felip, Enriqueta A1 Mancheño, Nuria A1 Juan, Oscar A1 Sanz, Julian A1 Gonzalez-Larriba, Jose Luis A1 Atienza-Cuevas, Lidia A1 Arriola-Arellano, Esperanza A1 Abdulkader, Ihab A1 Garcia-Gonzalez, Jorge A1 Camacho, Carmen A1 Rodriguez-Abreu, Delvys A1 Teixido, Cristina A1 Reguart, Noemi A1 Gonzalez-Piñeiro, Ana A1 Lazaro-Quintela, Martin A1 Lozano, Maria Dolores A1 Gurpide, Alfonso A1 Gomez-Roman, Javier A1 Lopez-Brea, Marta A1 Pijuan, Lara A1 Salido, Marta A1 Arriola, Edurne A1 Company, Amparo A1 Insa, Amelia A1 Esteban-Rodriguez, Isabel A1 Saiz, Monica A1 Azkona, Eider A1 Alvarez, Ramiro A1 Artal, Angel A1 Plaza, Maria Luz A1 Aguiar, David A1 Enguita, Ana Belen A1 Benito, Amparo A1 Paz-Ares, Luis A1 Garrido, Pilar A1 Lopez-Rios, Fernando K1 FISH K1 Immunohistochemistry K1 Lung carcinoma K1 Next-generation sequencing K1 ROS1 AB 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. 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). 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 The new SP384 ROS1 IHC clone showed excellent sensitivity without compromising specificity, so it is another excellent analytical option for the proposed testing algorithm. YR 2019 FD 2019-07-23 LK http://hdl.handle.net/10668/14313 UL http://hdl.handle.net/10668/14313 LA en DS RISalud RD Apr 11, 2025