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Related Experiment Video

Updated: Jan 8, 2026

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Blood-Based Biomarkers for Pulmonary Nodule Risk Stratification: A Systematic Review and Meta-Analysis.

Muhammad Perwaiz1, Kanwal Latif2, Anesha White2

  • 1Mount Sinai Elmhurst Hospital.

Journal of Bronchology & Interventional Pulmonology
|December 24, 2025
PubMed
Summary

Blood tests show promise for diagnosing pulmonary nodules, helping to rule out cancer. Circulating cell-free DNA fragmentomics assays offer the most accurate results for lung nodule management.

Keywords:
biomarkerearly detectionlung cancermeta-analysispulmonary nodule

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Area of Science:

  • Pulmonary Medicine
  • Oncology
  • Biomarker Discovery

Background:

  • Indeterminate pulmonary nodules require accurate diagnosis to differentiate benign from malignant cases.
  • Current diagnostic methods can be invasive, leading to potential complications and increased healthcare costs.

Purpose of the Study:

  • To evaluate the diagnostic performance of blood-based biomarker assays for distinguishing malignant from benign indeterminate pulmonary nodules.
  • To assess the clinical utility of these assays in managing patients with pulmonary nodules.

Main Methods:

  • Systematic review and meta-analysis of 13 studies (n=2771 patients) involving proteomic assays, circulating cell-free DNA (cfDNA) fragmentomics, and integrated models.
  • Pooled sensitivity, specificity, and AUC were estimated using random-effects models.
  • Risk of bias and publication bias were assessed.

Main Results:

  • Overall pooled sensitivity was 84.6%, specificity 65.3%, and AUC 0.78.
  • cfDNA fragmentomics assays achieved the highest accuracy (AUC: 0.87), performing well across diverse patient groups and nodule types.
  • A negative predictive value of 96% suggests strong utility for excluding malignancy.

Conclusions:

  • Blood-based biomarker assays, especially cfDNA fragmentomics, show potential as adjunctive tools for pulmonary nodule management.
  • These assays may help reduce unnecessary invasive procedures by effectively ruling out malignancy.
  • Further large-scale prospective studies are warranted to expand clinical applications.