Correlation of ROS1 Immunohistochemistry With ROS1 Fusion Status Determined by Fluorescence In Situ Hybridization
Richard S P Huang1, Derek Smith1, Catherine H Le1
1From Roche Molecular Solutions, Pleasanton, California (Dr Huang, Mr Smith, Dr Le, Mr Liu, Dr Ordinario, Dr Manohar, Mr Lee, Mr Rajamani, Mr Truong, Dr Jing Li, Ms Choi, Dr Jingchuan Li, Dr Pati, Dr Hanlon Newell, Mr Pate, and Dr Menzl); Institute of Pathology, University Hospital Basel, Basel, Switzerland (Dr Bubendorf); Institute for Pathology, University Hospital, Cologne, Germany (Dr Buettner); the Department of Pathology, Aberdeen University Medical School & Aberdeen Royal Infirmary, Foresterhill, Aberdeen, United Kingdom (Dr Kerr); Laboratorio de Dianas Terapeuticas, HM Hospitales, Spain (Dr Lopez-Rios); Center of Predictive Molecular Medicine, CeSIMeT, University of Chieti-Pescara, Italy (Dr Marchetti); Pfizer Oncology, International Developed Markets, Berlin, Germany (Dr Marondel); the Department of Histopathology, Royal Brompton and Harefield Hospitals, and National Heart and Lung Division, Imperial College, London, United Kingdom (Dr Nicholson); the Pathology Department, Istanbul University, Cerrahpassa Medical Faculty, Istanbul, Turkey (Dr Öz); CORE, Antwerp University, and the Department of Pathology, Antwerp University Hospital, Antwerp, Belgium (Dr Pauwels); the Department of Biopathology, Centre Jean Perrin & INSERM U240 IMoST and Université Clermont Auvergne, Clermont-Ferrand, France (Dr Penault-Llorca); Operative Unit of Pathology, AUSL della Romagna, Hospital S. Maria delle Croci, Ravenna, Italy (Dr Rossi); and the Department of Pathology, VU University Medical Center, Amsterdam, the Netherlands (Dr Thunnissen).
Determining ROS1 status is crucial for lung adenocarcinoma patients. The VENTANA ROS1 (SP384) antibody shows high correlation with FISH, offering a reliable method for ROS1-positive diagnosis.
Area of Science:
- Oncology
- Molecular Diagnostics
- Pathology
Background:
- Accurate ROS1 status determination is essential for guiding targeted therapy in lung adenocarcinoma.
- Crizotinib is approved for ROS1-positive non-small cell lung cancer (NSCLC).
Purpose of the Study:
- To analytically correlate the VENTANA ROS1 (SP384) Rabbit Monoclonal Primary Antibody with ROS1 fluorescence in situ hybridization (FISH).
Main Methods:
- 122 NSCLC samples were analyzed using immunohistochemistry (IHC) and FISH.
- Discrepant cases were further examined by RT-PCR and NGS (DNA and RNA).
- A consensus ROS1 status was established using five different methods.
Main Results:
- The IHC method, with specific cytoplasmic staining criteria (2+ or above in >30% of tumor cells), demonstrated high agreement with FISH-positive status (97.8% positive, 89.5% negative agreement).
- The ROS1 (SP384) antibody, using the defined IHC cutoff, achieved 100% positive and 92.0% negative agreement with the consensus ROS1 status.
- A standardized staining protocol for the ROS1 (SP384) antibody was developed.
Conclusions:
- The ROS1 (SP384) antibody demonstrates a high correlation with established methods for ROS1 status determination in NSCLC.
- This antibody, with a standardized protocol, offers a reliable and accurate diagnostic tool for identifying ROS1-positive lung adenocarcinoma.
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