TY - JOUR
T1 - Clinical validation and utility of Percepta GSC for the evaluation of lung cancer
AU - The AEGIS Study Team
AU - The Percepta Registry Investigators
AU - Mazzone, Peter
AU - Dotson, Travis
AU - Wahidi, Momen M.
AU - Bernstein, Michael
AU - Lee, Hans J.
AU - Kopman, David Feller
AU - Yarmus, Lonny
AU - Whitney, Duncan
AU - Stevenson, Christopher
AU - Qu, Jianghan
AU - Johnson, Marla
AU - Walsh, P. Sean
AU - Huang, Jing
AU - Lofaro, Lori R.
AU - Bhorade, Sangeeta M.
AU - Kennedy, Giulia C.
AU - Spira, Avrum
AU - Rivera, M. Patricia
N1 - Funding Information:
AS and CS are employed and receive salary support from Johnson & Johnson, and hold stock and stock options with Johnson & Johnson. DW was previously employed by Johnson & Johnson. JQ, MJ, PSW, LRL, JH, SMB, and GCK are employed and receive salary support from Veracyte, Inc. The funders had a role in study design, data collection and analysis, decision to
Publisher Copyright:
© 2022 Mazzone et al. This is an open access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited.
PY - 2022/7
Y1 - 2022/7
N2 - 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.
AB - 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.
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U2 - 10.1371/journal.pone.0268567
DO - 10.1371/journal.pone.0268567
M3 - Article
C2 - 35830375
AN - SCOPUS:85134306852
SN - 1932-6203
VL - 17
JO - PloS one
JF - PloS one
IS - 7 July
M1 - e0268567
ER -