TY - JOUR
T1 - The presence of circulating genetically abnormal cells in blood predicts risk of lung cancer in individuals with indeterminate pulmonary nodules
AU - Tahvilian, Shahram
AU - Kuban, Joshua D.
AU - Yankelevitz, David F.
AU - Leventon, Daniel
AU - Henschke, Claudia I.
AU - Zhu, Jeffrey
AU - Baden, Lara
AU - Yip, Rowena
AU - Hirsch, Fred R.
AU - Reed, Rebecca
AU - Brown, Ashley
AU - Muldoon, Allison
AU - Trejo, Michael
AU - Katchman, Benjamin A.
AU - Donovan, Michael J.
AU - Pagano, Paul C.
N1 - Funding Information:
This study was sponsored by LungLife AI. The authors thank the investigators and participants who volunteered in this study. Stephanie Weng, PhD provided medical writing support, which was funded by LungLife AI. We thank Lucia Chen, PhD for providing statistical support, which was funded by LungLife AI.
Funding Information:
Funding for the study was provided by LungLifeAI, Inc. LungLifeAI, Inc. drafted the study, oversaw the analysis and manuscript preparation, and approved the decision to publish.
Publisher Copyright:
© 2023, The Author(s).
PY - 2023/12
Y1 - 2023/12
N2 - Purpose: Computed tomography is the standard method by which pulmonary nodules are detected. Greater than 40% of pulmonary biopsies are not lung cancer and therefore not necessary, suggesting that improved diagnostic tools are needed. The LungLB™ blood test was developed to aid the clinical assessment of indeterminate nodules suspicious for lung cancer. LungLB™ identifies circulating genetically abnormal cells (CGACs) that are present early in lung cancer pathogenesis. Methods: LungLB™ is a 4-color fluorescence in-situ hybridization assay for detecting CGACs from peripheral blood. A prospective correlational study was performed on 151 participants scheduled for a pulmonary nodule biopsy. Mann-Whitney, Fisher’s Exact and Chi-Square tests were used to assess participant demographics and correlation of LungLB™ with biopsy results, and sensitivity and specificity were also evaluated. Results: Participants from Mount Sinai Hospital (n = 83) and MD Anderson (n = 68), scheduled for a pulmonary biopsy were enrolled to have a LungLB™ test. Additional clinical variables including smoking history, previous cancer, lesion size, and nodule appearance were also collected. LungLB™ achieved 77% sensitivity and 72% specificity with an AUC of 0.78 for predicting lung cancer in the associated needle biopsy. Multivariate analysis found that clinical and radiological factors commonly used in malignancy prediction models did not impact the test performance. High test performance was observed across all participant characteristics, including clinical categories where other tests perform poorly (Mayo Clinic Model, AUC = 0.52). Conclusion: Early clinical performance of the LungLB™ test supports a role in the discrimination of benign from malignant pulmonary nodules. Extended studies are underway.
AB - Purpose: Computed tomography is the standard method by which pulmonary nodules are detected. Greater than 40% of pulmonary biopsies are not lung cancer and therefore not necessary, suggesting that improved diagnostic tools are needed. The LungLB™ blood test was developed to aid the clinical assessment of indeterminate nodules suspicious for lung cancer. LungLB™ identifies circulating genetically abnormal cells (CGACs) that are present early in lung cancer pathogenesis. Methods: LungLB™ is a 4-color fluorescence in-situ hybridization assay for detecting CGACs from peripheral blood. A prospective correlational study was performed on 151 participants scheduled for a pulmonary nodule biopsy. Mann-Whitney, Fisher’s Exact and Chi-Square tests were used to assess participant demographics and correlation of LungLB™ with biopsy results, and sensitivity and specificity were also evaluated. Results: Participants from Mount Sinai Hospital (n = 83) and MD Anderson (n = 68), scheduled for a pulmonary biopsy were enrolled to have a LungLB™ test. Additional clinical variables including smoking history, previous cancer, lesion size, and nodule appearance were also collected. LungLB™ achieved 77% sensitivity and 72% specificity with an AUC of 0.78 for predicting lung cancer in the associated needle biopsy. Multivariate analysis found that clinical and radiological factors commonly used in malignancy prediction models did not impact the test performance. High test performance was observed across all participant characteristics, including clinical categories where other tests perform poorly (Mayo Clinic Model, AUC = 0.52). Conclusion: Early clinical performance of the LungLB™ test supports a role in the discrimination of benign from malignant pulmonary nodules. Extended studies are underway.
KW - Early detection
KW - Indeterminate nodules
KW - Liquid biopsy
KW - Lung cancer
KW - Pulmonary nodules
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U2 - 10.1186/s12890-023-02433-4
DO - 10.1186/s12890-023-02433-4
M3 - Article
C2 - 37277788
AN - SCOPUS:85160985056
SN - 1471-2466
VL - 23
JO - BMC Pulmonary Medicine
JF - BMC Pulmonary Medicine
IS - 1
M1 - 193
ER -