Lung EpiCheck Biomarkers Development Study

Inclusion Criteria - Cases: * Age 50-80 years * Subjects who are currently smoking or former smokers, with at least 20 pack-years * Subjects with either A high suspicion for lung cancer, with planned biopsy or surgery to establish a definitive diagnosis within 60 days after enrollment or treatment naive lung cancer patients confirmed by pathology. Exclusion Criteria - Cases * Known diagnosis or treatment of cancer from any kind in the past 5 years, except of fully resected non-melanoma skin cancer or fully-resected carcinoma in situ of the cervix and except from the current lung cancer Inclusion Criteria - USPSTF risk * Age 50-80 years * Subjects who are currently smoking or former smokers, with at least 20 pack-years Exclusion Criteria - USPSTF risk \- Known diagnosis or treatment of cancer of any kind in the past 5 years, except for fully resected non-melanoma skin cancer or fully-resected carcinoma in situ of the cervix Inclusion Criteria - Healthy controls * Age 20-80 years * Never smoker or current / previous smoker \< 20 pack year history Exclusion Criteria - Healthy Controls * Known diagnosis or treatment of cancer of any kind in the past (lifetime), except for fully resected non-melanoma skin cancer or fully-resected carcinoma in situ of the cervix. * Not previously diagnosed with a lung lesion highly suspicious for cancer * Under follow up or work up for any lesion suspicious for any type of cancer * Presenting with fever with body temperature 100.4°F (38°C) or higher * Acute exacerbation or flare of an inflammatory condition requiring escalation in medical therapy within 14 days prior to blood draw * Pregnancy * Any history of blood product transfusion within 30 days prior to blood draw