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

Publication ,  Journal Article
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 ...
Published in: PLoS One
2022

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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Published In

PLoS One

DOI

EISSN

1932-6203

Publication Date

2022

Volume

17

Issue

7

Start / End Page

e0268567

Location

United States

Related Subject Headings

  • Respiratory Mucosa
  • Lung Neoplasms
  • Humans
  • General Science & Technology
  • Chromosome Mapping
  • Bronchoscopy
  • Biopsy
 

Citation

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Chicago
ICMJE
MLA
NLM
Mazzone, P., Dotson, T., Wahidi, M. M., Bernstein, M., Lee, H. J., Feller Kopman, D., … Percepta Registry Investigators, . (2022). Clinical validation and utility of Percepta GSC for the evaluation of lung cancer. PLoS One, 17(7), e0268567. https://doi.org/10.1371/journal.pone.0268567
Mazzone, Peter, Travis Dotson, Momen M. Wahidi, Michael Bernstein, Hans J. Lee, David Feller Kopman, Lonny Yarmus, et al. “Clinical validation and utility of Percepta GSC for the evaluation of lung cancer.PLoS One 17, no. 7 (2022): e0268567. https://doi.org/10.1371/journal.pone.0268567.
Mazzone P, Dotson T, Wahidi MM, Bernstein M, Lee HJ, Feller Kopman D, et al. Clinical validation and utility of Percepta GSC for the evaluation of lung cancer. PLoS One. 2022;17(7):e0268567.
Mazzone, Peter, et al. “Clinical validation and utility of Percepta GSC for the evaluation of lung cancer.PLoS One, vol. 17, no. 7, 2022, p. e0268567. Pubmed, doi:10.1371/journal.pone.0268567.
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. Clinical validation and utility of Percepta GSC for the evaluation of lung cancer. PLoS One. 2022;17(7):e0268567.

Published In

PLoS One

DOI

EISSN

1932-6203

Publication Date

2022

Volume

17

Issue

7

Start / End Page

e0268567

Location

United States

Related Subject Headings

  • Respiratory Mucosa
  • Lung Neoplasms
  • Humans
  • General Science & Technology
  • Chromosome Mapping
  • Bronchoscopy
  • Biopsy