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

Exclusion Criteria

• •All subjects
• •1. Evidence of any diagnosed cancer (including prior lung cancer) other than non-melanoma skin cancer or carcinoma in situ within 2 years prior to enrollment
• •2. Prior systemic therapy, definitive therapy, radiation, or surgical resection for any cancer diagnosis within 2 years prior to enrollment (with the exception of surgery for nonmelanoma skin cancer and biopsies)
• •3. Any history of hematologic malignancy or myelodysplasia within 2 years prior to enrollment
• •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 the participant's participation in the study
• •8. Past or current participation in any clinical study sponsored by DELFI Diagnostics or any history of a LDT (Laboratory Developed Test) for early detection of lung cancer by DELFI Diagnostics