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