Determination and Validation of a Multi-analyte Assay for Lung Cancer Screening

Inclusion Criteria

• Inclusion Criteria - Cases: - Current or past smokers, with at least 20 pack-years - Subjects with either A high suspicion for lung cancer, with planned surgery to establish a definitive diagnosis within 60 days after date of blood collection OR treatment naive lung cancer patients Exclusion Criteria - Cases: - Known diagnosis or treatment of any previous cancer, including lung cancer, in the past 5 years, except for fully resected non-melanoma skin cancer or fully-resected carcinoma in situ of the cervix - Current lung cancer is known to be stage III or IV by pathology. Inclusion Criteria - Screening: - Current or past smokers, with at least 20 pack-years, undergoing LDCT for lung cancer screening Exclusion Criteria - Screening: - Known diagnosis or treatment of any cancer, including lung cancer, in the past 5 years, except for fully resected non-melanoma skin cancer or fully-resected carcinoma in situ of the cervix - Subjects whose purpose of performing LDCT is for surveillance of a lung nodule