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Assessment of ROS1 Gene Rearrangement in Non-Small Cell Lung Cancer: Concordance Between ROS1 SP384
Claudia Andrea Gómez-González1, Gurdeniz Serin1, Pinar Gursoy2
1Department of Pathology, Ege University, Faculty of Medicine, İZMİR, TÜRKİYE.
Turk Patoloji Dergisi
|March 6, 2026
Summary
ROS1 immunohistochemistry (IHC) is a useful screening tool for non-small cell lung cancer, but FISH testing is recommended for confirmation. ROS1 IHC showed 71.43% sensitivity and 84.97% specificity in this study.
Area of Science:
- Oncology
- Molecular Pathology
- Diagnostic Techniques
Background:
- Non-small cell lung cancer (NSCLC) is a leading cause of cancer death globally and in Türkiye.
- Accurate molecular profiling is crucial for targeted therapy selection in NSCLC.
- ROS1 alterations are important predictive biomarkers for NSCLC treatment.
Purpose of the Study:
- To compare the diagnostic performance of ROS1 immunohistochemistry (IHC) and fluorescence in situ hybridization (FISH) for detecting ROS1 gene alterations in NSCLC.
- To evaluate the utility of ROS1 IHC as a screening tool in a single-center cohort.
Main Methods:
- Analysis of 200 NSCLC biopsy specimens (tissue and cytology) from 2019-2022.
- ROS1 SP384 IHC staining (H-Score) and reflex molecular testing (EGFR, ALK, ROS1) were performed.
- Comparison of IHC results with FISH for ROS1 alterations.
Main Results:
- ROS1 IHC positivity was observed in 16.9% (34/200) of cases.
- ROS1 FISH positivity was confirmed in 3.5% (7/200) of cases.
- ROS1 IHC demonstrated 71.43% sensitivity, 84.97% specificity, and 99.3% negative predictive value for detecting ROS1 alterations.
Conclusions:
- ROS1 IHC is a valuable screening method for identifying potential ROS1 alterations in NSCLC.
- FISH testing is recommended for confirmation of IHC results.
- Discordant cases may necessitate next-generation sequencing (NGS) or RT-PCR for comprehensive molecular profiling.