A Registry to Evaluate the Performance of the BDX-XL2 Test

Inclusion criteria

• Patient has provided informed consent to participate in the registry and agrees to comply with all protocol requirements.
• Patient meets the criteria for the intended use population of Nodify Lung testing:

• Patient is > 40 years of age at the time of the discovery of the lung nodule of concern.
• The maximal dimension of the patient's lung nodule of concern is > 8mm and < 30mm.
• The pre-test risk of cancer as determined by the Mayo risk prediction algorithm is 65% or less.
• The first CT scan identifying the lung nodule of concern was performed within 60 days of patient enrollment in the registry.

Exclusion criteria

• Nodule work-up before the time of patient enrollment indicating any attempted or completed biopsy procedure after the first CT scan identifying the lung nodule of concern.
• High risk per physician assessment (i.e. > 65% by physician pCA)
• Current diagnosis of any active cancer.
• Prior diagnosis of lung cancer.
• Prior diagnosis of any cancer within 5 years of lung nodule detection, except for non-melanomatous skin cancer.
• Concurrent participation in any unrelated clinical trial that may impact or alter the management of the patient's nodule of concern.
• Any illness or factor that will prevent compliance with follow-up as recommended.