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Updated: Jun 26, 2025
Author Spotlight: Advancements in Molecular Biomarker Testing for Non-Squamous Non-Small Cell Lung Cancer
Published on: September 8, 2023
The Current Achievements of Multi-Gene Panel Tests in Clinical Settings for Patients with Non-Small-Cell Lung Cancer
Tadashi Sakaguchi1, Akemi Iketani2, Seiya Esumi1
1Department of Respiratory Medicine, Matsusaka Municipal Hospital, 1550, Tonomachi, Matsusaka 515-0073, Mie, Japan.
Abstract:
Some multi-gene panel tests have been implemented in clinical settings to guide targeted therapy in non-small-cell lung cancer (NSCLC) in Japan. The current performance of multi-gene panel tests under the condition that the Oncomine Dx Target Test (ODxTT) and Amoy Dx® Pan Lung Cancer PCR panel (AmoyDx-multi) are available remains relatively unknown. We retrospectively reviewed consecutive patients with NSCLC, whose FFPE samples were considered for genetic testing. We assessed the submission rates, the success rates, and the driver oncogene detection rates of multi-gene panel tests. A total of 225 patients were histologically newly diagnosed with NSCLC or diagnosed with a recurrence of NSCLC without a previous multi-gene panel test at our institution. Among the 225 patients, the FFPE samples of 212 patients (94.2%) were submitted for multi-gene panel testing, including 191 samples (84.9%) for the ODxTT and 21 samples (9.3%) for the AmoyDx-multi. Among the 212 samples submitted to multi-gene panel tests, the success rate was 99.5% (211/212). The detection rate of driver oncogene alterations for all histologies was 52.4% (111/212), and that for adenocarcinoma was 69.7% (106/152). A favorable submission rate and success rate of multi-gene panel tests were shown, along with a favorable detection rate in recent clinical settings.
Insights
Multi-gene panel tests show high success and driver oncogene detection rates in non-small cell lung cancer (NSCLC) patients in Japan. These tests are crucial for guiding targeted therapy in NSCLC.
Area of Science:
- Oncology
- Molecular Diagnostics
- Genetics
Background:
- Multi-gene panel tests are increasingly used for targeted therapy in non-small cell lung cancer (NSCLC).
- The performance of specific tests like Oncomine Dx Target Test (ODxTT) and Amoy Dx Pan Lung Cancer PCR panel (AmoyDx-multi) in Japanese clinical settings is not well-documented.
Purpose of the Study:
- To evaluate the current performance of multi-gene panel tests in NSCLC patients in Japan.
- To assess submission rates, success rates, and driver oncogene detection rates of ODxTT and AmoyDx-multi.
Main Methods:
- Retrospective review of consecutive NSCLC patients undergoing genetic testing.
- Analysis of FFPE samples for multi-gene panel testing, including ODxTT and AmoyDx-multi.
- Assessment of submission, success, and driver oncogene detection rates.
Main Results:
- 94.2% of 225 NSCLC patients had FFPE samples submitted for multi-gene panel testing (ODxTT: 84.9%, AmoyDx-multi: 9.3%).
- The overall success rate for submitted samples was high at 99.5% (211/212).
- Driver oncogene alterations were detected in 52.4% of all NSCLC cases and 69.7% of adenocarcinoma cases.
Conclusions:
- Multi-gene panel testing demonstrates favorable submission and success rates in contemporary clinical practice for NSCLC in Japan.
- These tests effectively detect driver oncogene alterations, supporting their role in guiding targeted therapy for NSCLC patients.
