CASCADE-LUNG: Cancer Screening Assay Using DELFI; A Clinical Validation Study in Lung

Inclusion Criteria:

• All subjects

1. Ability to understand and provide written informed consent

2. Age ≥ 50 years

3. Current or former smoker

4. ≥ 20 pack-years (pack years = number of packs per day × number of years smoked)

5. An initial or annual follow-up lung cancer screening chest CT planned/scheduledwithin 30 days after enrollment (i.e., enrollment chest CT scan)

Exclusion Criteria:

• All subjects

1. Evidence of any diagnosed cancer (including prior lung cancer) other thannon-melanoma skin cancer or carcinoma in situ within 2 years prior toenrollment

2. Prior systemic therapy, definitive therapy, radiation, or surgical resectionfor any cancer diagnosis within 2 years prior to enrollment (with the exceptionof surgery for nonmelanoma skin cancer and biopsies)

3. Any history of hematologic malignancy or myelodysplasia within 2 years prior toenrollment

4. Any history of organ tissue transplantation

5. Any history of blood product transfusion within 120 days prior to enrollment

6. Current pregnancy

7. Any condition that in the opinion of the Investigator should preclude theparticipant's participation in the study

8. Past or current participation in any clinical study sponsored by DelfiDiagnostics or any history of a LDT (Laboratory Developed Test) for earlydetection of lung cancer by Delfi Diagnostics