Clinical validation and utility of Percepta GSC for the evaluation of lung cancer.

Journal Article (Journal Article;Multicenter Study)

The Percepta Genomic Sequencing Classifier (GSC) was developed to up-classify as well as down-classify the risk of malignancy for lung lesions when bronchoscopy is non-diagnostic. We evaluated the performance of Percepta GSC in risk re-classification of indeterminate lung lesions. This multicenter study included individuals who currently or formerly smoked undergoing bronchoscopy for suspected lung cancer from the AEGIS I/ II cohorts and the Percepta Registry. The classifier was measured in normal-appearing bronchial epithelium from bronchial brushings. The sensitivity, specificity, and predictive values were calculated using predefined thresholds. The ability of the classifier to decrease unnecessary invasive procedures was estimated. A set of 412 patients were included in the validation (prevalence of malignancy was 39.6%). Overall, 29% of intermediate-risk lung lesions were down-classified to low-risk with a 91.0% negative predictive value (NPV) and 12.2% of intermediate-risk lesions were up-classified to high-risk with a 65.4% positive predictive value (PPV). In addition, 54.5% of low-risk lesions were down-classified to very low risk with >99% NPV and 27.3% of high-risk lesions were up-classified to very high risk with a 91.5% PPV. If the classifier results were used in nodule management, 50% of patients with benign lesions and 29% of patients with malignant lesions undergoing additional invasive procedures could have avoided these procedures. The Percepta GSC is highly accurate as both a rule-out and rule-in test. This high accuracy of risk re-classification may lead to improved management of lung lesions.

Full Text

Duke Authors

Cited Authors

  • Mazzone, P; Dotson, T; Wahidi, MM; Bernstein, M; Lee, HJ; Feller Kopman, D; Yarmus, L; Whitney, D; Stevenson, C; Qu, J; Johnson, M; Walsh, PS; Huang, J; Lofaro, LR; Bhorade, SM; Kennedy, GC; Spira, A; Rivera, MP; AEGIS Study Team, ; Percepta Registry Investigators,

Published Date

  • 2022

Published In

Volume / Issue

  • 17 / 7

Start / End Page

  • e0268567 -

PubMed ID

  • 35830375

Pubmed Central ID

  • PMC9278743

Electronic International Standard Serial Number (EISSN)

  • 1932-6203

Digital Object Identifier (DOI)

  • 10.1371/journal.pone.0268567

Language

  • eng

Conference Location

  • United States