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Updated: Nov 24, 2025
Author Spotlight: Advancements in Molecular Biomarker Testing for Non-Squamous Non-Small Cell Lung Cancer
Published on: September 8, 2023
Feasibility of next-generation sequencing test for patients with advanced NSCLC in clinical practice
Ryo Ariyasu1, Ken Uchibori1, Hironori Ninomiya2,3
1Department of Thoracic Medical Oncology, The Cancer Institute Hospital, Japanese Foundation for Cancer Research, Tokyo, Japan.
Background:
The usefulness of the Oncomine Dx Target test (Oncomine Dx), a next-generation sequencing (NGS) test, has already been proven in clinical trials. However, NGS requires high-quality tumor samples and takes a long time to generate results. The feasibility of NGS for use in advanced non-small cell lung cancer (NSCLC) patients in clinical practice has not yet been determined.
Methods:
Patients serially diagnosed with advanced NSCLC were evaluated in our hospital. The Oncomine Dx, Cobas EGFR mutation test (Cobas EGFR), and ALK-IHC were performed. The patients were divided into four sets: the full analysis set (FAS) that referred to patients diagnosed with NSCLC, the intent to perform companion diagnostics (CDx) set (IPS) that referred to patients in which CDx had been ordered regardless of sample quality, the per-performed CDx set (PPS) that referred to patients who could undergo CDx regardless of the results, and the per-completed CDx set (CCS) that referred to patients in which informative results were received from the CDx.
Results:
The total number of patients analyzed in the study was 167. The IPS/FAS of Oncomine Dx (80.2%) was lower than that of the ALK-IHC (85.0%) and Cobas EGFR (92.8%). The CCS/FAS of Oncomine Dx (65.9%) was lower than that of the ALK-IHC (82.0%) and Cobas EGFR (92.2%). PPS/IPS and CCS/PPS of the Oncomine Dx with nonsurgical biopsy ranged between 78.6% and 90.9%, which was lower than those patients who underwent surgical resection (95.0% and 100%).
Conclusions:
The feasibility of Oncomine Dx in clinical practice was lower than the other CDx. The feasibility of Oncomine Dx will increase by improving the biopsy procedure.
Key Points:
SIGNIFICANT STUDY FINDINGS: The usefulness of a next-generation sequencing (NGS) test has been proven in clinical trials. The feasibility of NGS is lower than other diagnostics in clinical practice especially with regard to nonsurgical biopsy.
What This Study Adds:
It is necessary to improve the feasibility of NGS in clinical practice. To improve NGS feasibility, turnaround time must be shortened, and larger samples must be obtained during surgical procedures.
Insights
The Oncomine Dx next-generation sequencing (NGS) test shows lower feasibility in clinical practice for advanced non-small cell lung cancer (NSCLC) patients compared to other diagnostics. Improving biopsy procedures is key to enhancing NGS utility.
Area of Science:
- Oncology
- Molecular Diagnostics
- Genomics
Background:
- Next-generation sequencing (NGS) tests like Oncomine Dx are valuable but require high-quality samples and have long turnaround times.
- The clinical practice feasibility of NGS for advanced non-small cell lung cancer (NSCLC) remains undetermined.
Purpose of the Study:
- To evaluate the feasibility of the Oncomine Dx test in comparison to other companion diagnostics (CDx) for advanced NSCLC patients in a real-world clinical setting.
Main Methods:
- A cohort of advanced NSCLC patients underwent Oncomine Dx, Cobas EGFR mutation test, and ALK-IHC testing.
- Patients were categorized into four sets: Full Analysis Set (FAS), Intent to Perform CDx (IPS), Per-Performed CDx (PPS), and Per-Completed CDx (CCS).
Main Results:
- Oncomine Dx showed lower IPS/FAS (80.2%) and CCS/FAS (65.9%) compared to ALK-IHC and Cobas EGFR.
- Feasibility rates for Oncomine Dx were lower with nonsurgical biopsies (78.6%-90.9%) than with surgical resections (95.0%-100%).
Conclusions:
- The Oncomine Dx test demonstrated lower feasibility in clinical practice compared to other CDx for advanced NSCLC.
- Improving biopsy procedures, shortening turnaround times, and obtaining larger samples are crucial for enhancing NGS feasibility.
