Background: Few studies have evaluated EGFR status concordance of multiple genomic tests using real-world data (RWD). Results of metastatic Non–Small Cell Lung Cancer (NSCLC) patients with multiple EGFR genomic tests within the ConcertAI Genome360 dataset were evaluated. Methods: The analysis included patients initially diagnosed with NSCLC from February 26, 2015 to December 6, 2021 with EGFR status determined using genomic tests for at least one blood and one tumor tissue specimen within -30 days to +90 days of the metastatic diagnosis date. Type and number of specimens, number of genomic laboratories used, number of tests utilized, and number of biomarker test methods (Table 1) were captured at the patient level. Patients were classified as positive (positive/equivocal/high) or negative based on the test results. Patients with insufficient samples, tests not conducted, technical problems, or indeterminate results were not included. Results: The dataset from which the study sample was drawn included 5389 metastatic NSCLC patients with at least one EGFR test. Of these, 583 (10.8%) patients (52% female, mean age [SD] of 68 [10.18]) with 2058 tests for the various biomarker variant types for EGFR were eligible for this study. Among the 583 patients, there was a mean of 2.00 specimen types, 1.86 genomic laboratories, 3.53 tests, and 1.39 biomarker test methods at a per patient level. Overall, 527 (90.4%) of the patients had matching results from multiple tests, and 56 (9.6%) of the patients had at least one pair of non-matching results. Of the non-matching results, 35 (62.5%) were due to presence of benign variant or variants of uncertain significance. Only 21 of the 583 patients (3.6%) had evidence of non-matching results for a pathogenic variant, which required a minimum of one positive and negative result. Conclusions: Despite differences in specimen types, RWD indicate a relatively high level of concordance among laboratories, tests, and biomarker test methods, with only 3.6% of the patients having non-matching results.
Variation element in EGFR testing.
