Comparison between next‐generation sequencing and multiplex polymerase chain reaction assays for nonsmall‐cell lung cancer molecular diagnosis

Abstract 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.