Scientific publications
Assessment of a New ROS1 Immunohistochemistry Clone (SP384) for the Identification of ROS1 Rearrangements in Non-Small Cell Lung Carcinoma Patients: the ROSING Study
Conde E (1), Hernandez S (2), Martinez R (2), Angulo B (1), De Castro J (3), Collazo-Lorduy A (2), Jimenez B (2), Muriel A (4), Mate JL (5), Moran T (6), Aranda I (7), Massuti B (7), Rojo F (8), Domine M (9), Sansano I (10), Garcia F (11), Felip E (10), Mancheño N (12), Juan O (12), Sanz J (13), Gonzalez-Larriba JL (13), Atienza-Cuevas L (14), Arriola-Arellano E (14), Abdulkader I (15), Garcia-Gonzalez J (15), Camacho C (16), Rodriguez-Abreu D (16), Teixido C (17), Reguart N (17), Gonzalez-Piñeiro A (18), Lazaro-Quintela M (18), Lozano MD (19), Gurpide A (19), Gomez-Roman J (20), Lopez-Brea M (20), Pijuan L (21), Salido M (21), Arriola E (21), Company A (22), Insa A (22), Esteban-Rodriguez I (3), Saiz M (23), Azkona E (23), Alvarez R (24), Artal A (24), Plaza ML (25), Aguiar D (25), Enguita AB (26), Benito A (27), Paz-Ares L (28), Garrido P (29), Lopez-Rios F (30)
INTRODUCTION:
The ROS1 gene rearrangement has become an important biomarker in non-small cell lung carcinomas (NSCLCs). The CAP/IASLC/AMP 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:
Forty-three ROS1 FISH-positive and 193 ROS1 FISH-negative NSCLC samples were studied. All specimens were screened by two antibodies (clone D4D6 from Cell Signaling Technology and clone SP384 from Ventana) and the different interpretation criteria were compared with break-apart FISH (Vysis). FISH-positive samples were also analyzed with next-generation sequencing (OncomineTM Dx, Thermo Fisher Scientific).
RESULTS:
An H-score of ≥150 or the presence of ≥70% of ≥2+ stained tumor cells by SP384 clone were the optimal cut-off value (both with 93% sensitivity and 100% specificity). The D4D6 clone showed similar results with an H-score of ≥100 (91% sensitivity and 100% specificity). ROS1 expression in normal lung was more frequent using the SP384 clone (P < 0.0001). 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.
CITATION J Thorac Oncol. 2019 Jul 23. pii: S1556-0864(19)30562-3. doi: 10.1016/j.jtho.2019.07.005
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