Nodify XL2 Classifier Clinical Utility Study in Low to Moderate Risk Lung Nodules

1. Subject has provided informed consent to participate in the study and agrees to comply with all protocol requirements

2. Subject is > 40 years of age at the time of the discovery of the lung nodule of concern

3. Subject's lung nodule of concern meets the following:

4. The first CT scan identifying the lung nodule of concern was performed within 60 days of subject enrollment

5. The pre-test risk of cancer as determined by the Mayo risk prediction algorithm is 65% or less

1. Nodule work-up at the time of subject enrollment indicating any prior attempted or completed diagnostic biopsy procedure or blood-based testing for the lung nodule of concern

2. Nodule of concern is part-solid or Ground Glass Opacity (GGO)

3. Prior diagnosis of lung cancer

4. Any active cancer within 5-years of nodule detection, with the exception of non-melanoma skin cancer

5. Administration of blood products (i.e. packed red blood cells, fresh frozen plasma, or platelets) within 30 days of subject enrollment

6. Concurrent participation in any unrelated clinical trial that may impact or alter the management of the subject's nodule of concern

7. Any illness or factor that will inhibit compliance with study participation