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Updated: Oct 15, 2025
Author Spotlight: Advancements in Molecular Biomarker Testing for Non-Squamous Non-Small Cell Lung Cancer
Published on: September 8, 2023
Real-world data on NGS using the Oncomine DxTT for detecting genetic alterations in non-small-cell lung cancer:
Shinya Sakata1, Kohei Otsubo2, Hisako Yoshida3
1Department of Respiratory Medicine, Kumamoto University Hospital, Kumamoto, Japan.
Abstract:
Considering the increasing number of identified driver oncogene alterations, additional genetic tests are required to determine the treatment for advanced non-small-cell lung cancer (NSCLC). Next-generation sequencing can detect multiple driver oncogenes simultaneously, enabling the analysis of limited amounts of biopsied tissue samples. In this retrospective, multicenter study (UMIN ID000039523), we evaluated real-world clinical data using the Oncomine Dx Target Test Multi-CDx System (Oncomine DxTT) as a companion diagnostic system. Patients with NSCLC who were tested for a panel of 46 genes using the Oncomine DxTT between June 2019 and January 2020 were eligible for enrollment. Patients from 19 institutions affiliated to the West Japan Oncology Group were recruited. The primary endpoint of the study was the success rate of genetic alteration testing in four driver genes (EGFR, ALK, ROS1, and BRAF) using the Oncomine DxTT. In total, 533 patients were enrolled in the study. The success rate of genetic alteration testing for all four genes was 80.1% (95% CI 76.5%-83.4%). Surgical resection was associated with the highest success rate (88.0%), which was significantly higher than that for bronchoscopic biopsy (76.8%, P = .005). Multivariate analysis revealed a significant difference for surgical resection alone (P = .006, 95% CI 1.36-6.18, odds ratio 2.90). Although the success rate of genetic alteration testing immediately after Oncomine DxTT induction was not sufficient in this study, optimizing specimen quantity and quality may improve the use of driver gene testing in clinical settings.
Insights
Genetic testing for advanced non-small-cell lung cancer (NSCLC) using the Oncomine Dx Target Test achieved an 80.1% success rate. Surgical resection samples yielded higher success rates than bronchoscopic biopsies.
Area of Science:
- Oncology
- Genetics
- Molecular Diagnostics
Background:
- Advanced non-small-cell lung cancer (NSCLC) treatment relies on identifying driver oncogene alterations.
- Next-generation sequencing (NGS) enables simultaneous detection of multiple driver oncogenes from limited tissue samples.
- The Oncomine Dx Target Test Multi-CDx System (Oncomine DxTT) is a companion diagnostic for comprehensive gene panel testing.
Purpose of the Study:
- To evaluate the real-world success rate of genetic alteration testing for four key driver genes (EGFR, ALK, ROS1, BRAF) in NSCLC patients using the Oncomine DxTT.
- To compare the success rates of genetic testing based on different tissue biopsy methods.
Main Methods:
- Retrospective, multicenter study involving 533 NSCLC patients from 19 institutions.
- Patients underwent 46-gene panel testing using the Oncomine DxTT between June 2019 and January 2020.
- Primary endpoint: success rate of genetic alteration testing for EGFR, ALK, ROS1, and BRAF.
Main Results:
- The overall success rate for genetic alteration testing of the four driver genes was 80.1%.
- Surgical resection samples showed a significantly higher success rate (88.0%) compared to bronchoscopic biopsy (76.8%, P = .005).
- Multivariate analysis confirmed surgical resection alone as a significant factor (P = .006, OR 2.90).
Conclusions:
- The Oncomine DxTT demonstrated a moderate success rate for driver gene testing in advanced NSCLC.
- Optimizing specimen quantity and quality is crucial for improving the utility of driver gene testing in clinical practice.
- Surgical resection is a preferred method for obtaining adequate tissue for comprehensive genomic profiling in NSCLC.
