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Updated: Nov 26, 2025
Author Spotlight: Advancements in Molecular Biomarker Testing for Non-Squamous Non-Small Cell Lung Cancer
Published on: September 8, 2023
Comparison of the analytical performance between the Oncomine Dx Target Test and a conventional single gene test for
Tadashi Sakaguchi1, Akemi Iketani2, Kazuki Furuhashi1
1Respiratory Center, Matsusaka Municipal Hospital, Matsusaka, Japan.
Background:
Next-generation sequencing (NGS) has been implemented in clinical oncology to analyze multiple genes and to guide targeted therapy; however, little is known about the performance of the Oncomine Dx Target Test compared with conventional single gene tests for detecting EGFR mutations. The objective of this study was to evaluate the performance of the Oncomine Dx Target Test compared with a PNA-LNA PCR clamp test to detect EGFR mutations.
Methods:
We retrospectively reviewed consecutive patients with non-small cell lung cancer (NSCLC) from whom FFPE samples were simultaneously submitted for the Oncomine Dx Target Test, and a PNA-LNA PCR clamp test using the same specimen. We subsequently compared the analysis success rates and detection rates between the two tests.
Results:
A total of 116 samples were identified. The success rates and detection rates of EGFR mutations in the total number of samples were 90% and 28%, respectively for the Oncomine Dx Target Test, and 100% and 35% for the PNA-LNA PCR clamp test. The Oncomine Dx Target Test was unable to analyze three samples (2%) due to the samples not passing the nucleic acid concentration threshold, and nine (8%) samples had invalid results. The exon 19 deletion was not detected by the Oncomine Dx Target Test in four cases (4%).
Conclusions:
The analytical performance of the Oncomine Dx Target Test analysis for EGFR mutations may not be comparable with conventional single gene tests due to both invalid and false-negative results.
Key Points:
Significant findings of the study The success rate of the Oncomine Dx Target Test was significantly lower than the PNA-LNA PCR clamp test. Among the samples successfully analyzed, four exon 19 deletions were not detected by the Oncomine Dx Target Test. What this study adds The analytical performance of the Oncomine Dx Target Test may not be comparable with conventional single gene tests. We should revise the sampling procedures, and review the sample quality assessment methods, to improve the analytical performance.
Insights
The Oncomine Dx Target Test showed a lower success rate for detecting EGFR mutations compared to the PNA-LNA PCR clamp test. This next-generation sequencing test yielded invalid and false-negative results, impacting its clinical utility.
Area of Science:
- Oncology
- Genetics
- Molecular Diagnostics
Background:
- Next-generation sequencing (NGS) is used in oncology for targeted therapy guidance.
- The performance of the Oncomine Dx Target Test for EGFR mutations is not well-established compared to single-gene tests.
Purpose of the Study:
- To evaluate the performance of the Oncomine Dx Target Test against a PNA-LNA PCR clamp test for detecting EGFR mutations.
Main Methods:
- Retrospective review of 116 non-small cell lung cancer (NSCLC) patient samples.
- Simultaneous testing using Oncomine Dx Target Test and PNA-LNA PCR clamp test.
- Comparison of analysis success and EGFR mutation detection rates.
Main Results:
- Oncomine Dx Target Test success rate: 90% (28% EGFR mutation detection).
- PNA-LNA PCR clamp test success rate: 100% (35% EGFR mutation detection).
- Oncomine Dx Target Test had 2% unanalyzable and 8% invalid results; missed 4% of exon 19 deletions.
Conclusions:
- The Oncomine Dx Target Test's analytical performance for EGFR mutations may not be comparable to conventional single-gene tests.
- Invalid and false-negative results indicate potential issues with the Oncomine Dx Target Test.
- Revising sampling procedures and quality assessment is recommended to improve performance.
