• Hans J Lee, Peter Mazzone, David Feller-Kopman, Lonny Yarmus, Kyle Hogarth, Lori R Lofaro, Bailey Griscom, Marla Johnson, Yoonha Choi, Jing Huang, Sangeeta Bhorade, Avrum Spira, Giulia C Kennedy, Momen M Wahidi, and Percepta Registry Investigators.
• Department of Medicine, Section of Interventional Pulmonology, Division of Pulmonary and Critical Care Medicine, Johns Hopkins School of Medicine, Baltimore, MD. Electronic address: hlee171@jhmi.edu.
• Chest. 2021 Jan 1; 159 (1): 401-412.

BackgroundThe Percepta genomic classifier has been clinically validated as a complement to bronchoscopy for lung nodule evaluation.Research QuestionThe goal of this study was to examine the impact on clinical management decisions of the Percepta result in patients with low- and intermediate-risk lung nodules.Study Design And MethodsA prospective "real world" registry was instituted across 35 US centers to observe physician management of pulmonary nodules following a nondiagnostic bronchoscopy. To assess the impact on management decisions of the Percepta genomic classifier, a subset of patients was analyzed who had an inconclusive bronchoscopy for a pulmonary nodule, a Percepta result, and an adjudicated lung diagnosis with at least 1 year of follow-up. In this cohort, change in the decision to pursue additional invasive procedures following Percepta results was assessed.ResultsA total of 283 patients met the study eligibility criteria. In patients with a low/intermediate risk of malignancy for whom the clinician had designated a plan for a subsequent invasive procedure, a negative Percepta result down-classified the risk of malignancy in 34.3% of cases. Of these down-classified patients, 73.9% had a change in their management plan from an invasive procedure to surveillance, and the majority avoided a procedure up to 12 months following the initial evaluation. In patients with confirmed lung cancers, the time to diagnosis was not significantly delayed when comparing Percepta down-classified patients vs patients who were not down-classified (P = .58).InterpretationThe down-classification of nodule malignancy risk with the Percepta test decreased additional invasive procedures without a delay in time to diagnosis among those with lung cancer.Copyright © 2020 American College of Chest Physicians. Published by Elsevier Inc. All rights reserved.

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