Impact of the Percepta Genomic Classifier on Clinical Management Decisions in a Multicenter Prospective Study.

ABSTRACT BACKGROUND The Percepta genomic classifier has been clinically validated as a complement to bronchoscopy for lung nodule evaluation. This study examines the impact on clinical management decisions of the Percepta result in patients with low/ intermediate risk lung nodules. METHODS We instituted a prospective “real world” registry across 35 U.S. centers to observe physician management of pulmonary nodules after a non-diagnostic bronchoscopy. To assess the impact on management decisions of the Percepta genomic classifier we analyzed a subset of patients who had an inconclusive bronchoscopy for a pulmonary nodule, a Percepta result, and an adjudicated lung diagnosis with at least one year of follow-up. In this cohort we assessed change in the decision to pursue additional invasive procedures following Percepta results. RESULTS A total of 283 patients met the study eligibility criteria. In patients with a low/ intermediate risk of malignancy where 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 after initial evaluation. In patients with confirmed lung cancers, the time to diagnosis was not significantly delayed when comparing Percepta down-classified patients to patients who were not down-classified (p=0.58) CONCLUSIONS The 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.