A Diagnostic Need

A Diagnostic Need

In the United States alone, it is estimated that the health care system spends millions of dollars per year on work-ups for suspicious lung nodules that are in the 8 - 20 mm size range and for patients who are 40 years of age or older. This is only expected to be exacerbated by the impending implementation of CT lung screening nationwide for high risk patients. After these patients undergo a series of diagnostic testing, including invasive procedures, a majority of these nodules are eventually diagnosed as benign.

Current diagnostic procedures have limitations and risk.(1)

False Positive 12.5-20.6%
False Negative 3.8-28.3%
Nodule Size Limit >10mm
False Negatives 30-70%
Bleeding 2-5%
Pneumothorax 2-4%
False Negatives 10-30%
Non-Diagnostic 1-55% (med.6%)
Pneumothorax 15%
Pneumothorax - Chest Tube 6-7%
False Positives 18-34%
Persistent Air Leak 3-5%
Pneumonia 1-8%
Death 0.5%

1. Gould et al. Evaluation of Individuals With Pulmonary Nodules: When Is It Lung Cancer? Diagnosis and Management of Lung Cancer, 3rd ed: American College of Chest Physicians Evidence-Based Clinical Practice Guidelines. CHEST 2013; 143(5)(Suppl):e93S–e120S

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