The Current Achievements of Multi-Gene Panel Tests in Clinical Settings for Patients with Non-Small-Cell Lung Cancer.

Simple Summary: Performing multi-gene testing for detecting driver oncogene alterations is essential to avoid missing treatment opportunities with appropriate targeted therapies, including in cases with rare driver oncogene alterations. However, multi-gene testing has not been sufficiently implemented under the condition that the Oncomine Dx Target Test is only available in clinical settings in Japan. This study evaluated the recent status of multi-gene panel tests in our institution under the condition that both the Oncomine Dx Target Test and Amoy Dx® Pan Lung Cancer PCR panel were available. A favorable submission rate and success rate of multi-gene testing were shown, along with a favorable detection rate in recent clinical settings. As our practice of multi-gene testing has matured and the number of options for multi-gene testing with different characteristics has increased, it has become feasible to perform multi-gene testing on the majority of patients with non-small-cell lung cancer. 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. [ABSTRACT FROM AUTHOR]