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