Clinical Research Directory

Inclusion Criteria: 1. The participant is willing and able to provide informed consent and agrees to comply with all protocol requirements. 2. The participant is an adult, 40 years of age or older at the time of enrollment. 3. The participant has at least one pulmonary nodule measuring 4mm to 30mm in maximum diameter based on CT imaging. 4. The pulmonary nodule of concern is solid or part solid. 5. The pulmonary nodule of concern was identified either incidentally or as part of a lung cancer screening program. 6. The participant has an estimated pre-test probability of malignancy (pCA) ≤65%, as determined by the treating physician using an established risk prediction model (e.g., Mayo Clinic Model) Exclusion Criteria: 1. History of lung cancer any time prior to enrollment or an active malignancy requiring treatment, active surveillance within 5 years prior to identification of the nodule of concern. 2. Pulmonary nodule of concern with a pre-test probability of malignancy (pCA) \>65%, as determined by the treating physician using an established risk prediction model (e.g., Mayo Clinic Model) 3. The pulmonary nodule of concern is a ground glass opacity (GGO) 4. Prior definitive diagnosis through histopathological confirmation or empiric radiation treatment of the nodule of concern. 5. Prior definitive diagnosis or empiric radiation treatment of the nodule of concern before enrollment 6. Prior use of Nodify CDT test, Nodify XL2 test, or another molecular classifier for evaluation of the index pulmonary nodule before enrollment. 7. Participation in another interventional clinical study or other lung nodule management related tests that, in the opinion of the investigator, could influence management or outcomes of the index pulmonary nodule.