Clinical Trials

Inclusion Criteria:

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:

- Was incidentally identified

- Is a solid nodule

- Has maximal dimension of > 8mm and < 30mm

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 50%
or less

Exclusion Criteria:

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

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

3. Nodule of concern was detected during lung cancer screening

4. Prior diagnosis of lung cancer

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

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

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

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