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Updated: Jun 29, 2025
Author Spotlight: Advancements in Molecular Biomarker Testing for Non-Squamous Non-Small Cell Lung Cancer
Published on: September 8, 2023
Comparison between next-generation sequencing and multiplex polymerase chain reaction assays for nonsmall-cell lung
Shuji Murakami1, Kanako Shinada1, Yuka Otsutsumi2
1Department of Thoracic Oncology, Kanagawa Cancer Center, Yokohama, Kanagawa, Japan.
Purpose:
Genetic mutation detection has become an important step in nonsmall-cell lung cancer (NSCLC) treatment because of the increasing number of drugs that target genomic rearrangements. A multiplex test that can detect multiple gene mutations prior to treatment is thus necessary. Currently, either next-generation sequencing (NGS)-based or polymerase chain reaction (PCR)-based tests are used. We evaluated the performance of the Oncomine Dx Target Test (ODxTT), an NGS-based multiplex biomarker panel test, and the AmoyDx Pan Lung Cancer PCR Panel (AmoyDx PLC panel), a real-time PCR-based multiplex biomarker panel test.
Materials And Methods:
Patients with histologically diagnosed NSCLC and a sufficient sample volume to simultaneously perform the AmoyDx PLC panel and ODxTT-M were included in the study. The success and detection rates of both tests were evaluated.
Results:
Biopsies revealed 116 cases of malignancies, 100 of which were NSCLC. Of these, 59 met the inclusion criteria and were eligible for analysis. The success rates were 100% and 98% for AmoyDx PLC panel and ODxTT-M, respectively. Nine driver mutations were detected in 35.9% and 37.3% of AmoyDx PLC and ODxTT-M panels, respectively. EGFR mutations were detected in 14% and 12% of samples using the AmoyDx PLC panel and ODxTT-M, respectively. Of the 58 cases in which both NGS and AmoyDx PLC panels were successful, discordant results were observed in seven cases. These differences were mainly due to different sensitivities of the detection methods used and the gene variants targeted in each test.
Discussion:
The AmoyDx PLC panel, a PCR-based multiplex diagnostic test, exhibits a high success rate. The frequency of the nine genes targeted for treatment detected by the AmoyDx PLC panel was comparable to the frequency of mutations detected by ODxTT-M. Clinicians should understand and use the AmoyDx PLC panel and ODxTT-M with respect to their respective performances and limitations.
Insights
The AmoyDx Pan Lung Cancer PCR Panel (PLC panel) shows a high success rate for detecting mutations in non-small-cell lung cancer (NSCLC). Its performance is comparable to the Oncomine Dx Target Test (ODxTT), offering a valuable diagnostic tool for NSCLC treatment.
Area of Science:
- Oncology
- Genetics
- Molecular Diagnostics
Background:
- Genetic mutation detection is crucial for targeted therapy in non-small-cell lung cancer (NSCLC).
- Multiplex tests are needed to identify multiple gene mutations simultaneously for effective treatment planning.
- Current methods include next-generation sequencing (NGS) and polymerase chain reaction (PCR)-based tests.
Purpose of the Study:
- To evaluate and compare the performance of an NGS-based test, the Oncomine Dx Target Test (ODxTT), and a real-time PCR-based multiplex test, the AmoyDx Pan Lung Cancer PCR Panel (AmoyDx PLC panel).
- To assess the success and detection rates of both multiplex biomarker panel tests in NSCLC patients.
Main Methods:
- A study was conducted on patients with histologically diagnosed NSCLC.
- Both the AmoyDx PLC panel and ODxTT-M were performed simultaneously on patient samples.
- Success rates and detection rates for driver mutations, including EGFR mutations, were evaluated.
Main Results:
- The AmoyDx PLC panel achieved a 100% success rate, while ODxTT-M had a 98% success rate.
- Nine driver mutations were detected in 35.9% of samples by the AmoyDx PLC panel and 37.3% by ODxTT-M.
- Concordant results were observed in most cases, with discrepancies mainly attributed to differences in test sensitivity and targeted gene variants.
Conclusions:
- The AmoyDx PLC panel demonstrates a high success rate and comparable mutation detection frequency to ODxTT-M for key genes in NSCLC.
- Clinicians should be aware of the specific performance characteristics and limitations of both the AmoyDx PLC panel and ODxTT-M for informed clinical decision-making.
- Both PCR-based and NGS-based multiplex tests are valuable tools for genetic mutation detection in NSCLC treatment.
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