- Age ≥ 40 years
- Smoking history: Never, Former, Current
- Subject undergoing diagnostic evaluation for a lung nodule
- Subject undergoing evaluation for a lung nodule by a pulmonologist, and/or by a thoracic surgeon
- Baseline CT scan identifying lung nodule performed within 60 days of subject enrollment
- Nodule(s) identified by CT scan previously not followed
- Subject willing to provide informed consent for the collection of blood specimens
Other eligibility criteria may apply.
- Nodule work-up at the time of enrollment eligibility indicates any prior attempted or completed diagnostic biopsy procedure, such as transthoracic needle aspiration, bronchoscopic biopsy or surgery
- A prior CT scan is available that previously identifies the same lung nodule under consideration for study inclusion on the most current CT scan; AND the prior CT scan was performed more than 60 days before the current CT scan, irrespective of the candidate nodule's radiographic characterization such as size, density or appearance
- Current diagnosis of any cancer
- Prior diagnosis of any cancer within 2 years of lung nodule detection, except for non-melanoma skin cancer
- Administration of blood products, e.g. packed red blood cells, fresh frozen plasma, or platelets, within 30 days of subject enrollment
- History of human immunodeficiency virus (HIV) or Hepatitis C
Other exclusion criteria may apply.