A Case-Control Study to Verify Diagnostic Performance of AminoIndex™ Technology

Inclusion Criteria All Groups: * Able to read, understand and sign informed consent to participate in study. * Willing and able to provide written informed consent. * Willing and able to meet all study requirements and undergo venipuncture to provide a fasting blood sample. Group 1: * Men or women age 18 years or older; * Lung nodule size ≥ 6 mm but ≤ 35 mm/ lung, nodule or mass. * Diagnosis of lung cancer based upon histopathology performed on lung nodule, lesion or mass tissue obtained from biopsy or surgical excision performed after study-related fasting blood sample obtained. Group 2: * Men or women age 18 years or older; * Lung nodule size ≥ 6 mm but ≤ 35 mm/ lung nodule, lesion or mass; * Definitive diagnosis of benign (non-cancerous) lung nodule based upon one of the following: * Histopathology performed on lung nodule tissue obtained from biopsy or surgical excision performed after study-related fasting blood sample obtained; * No nodule growth for \> 2 years by repeat CT imaging, the most recent being performed within the 60 days prior to signing informed consent. Group 3: * Men or women age 55-79 years inclusive; * Current smoker or quit \< 15 years ago with a \> 30 pack-year smoking history (equivalent of 1 pack per day for 30 or more years)\*. * Have undergone low-dose computed tomography (LDCT) or standard computed tomography (CT) or X-ray testing to screen for lung cancer with no nodules suspicious for lung cancer within 1 year prior to signing informed consent. ' \* ' One pack year is calculated as follows: 20 cigarettes = 1 pack. One "pack year" is the equivalent of smoking: * 20 cigarettes (one pack) per day for one year; or * 40 cigarettes (two packs) per day for 6 months; or * 60 cigarettes (three packs) per day for 3 months Exclusion Criteria * Inability to fast for 8 hours prior to the blood sample collection. * Known to be positive for HIV and/or, HBV and/or HCV. * Pregnancy. * Breastfeeding. * Currently undergoing dialysis. * Congenital metabolic disease. * Currently receiving investigational treatments of any type. * History of receiving any drug therapy or surgery for the treatment of lung cancer. * Diagnosis of cancer within past 5 years and/or currently undergoing treatment for any cancer. * Any clinical condition, diagnosis, or social circumstance that, in the opinion of the Investigator, would be mean participation in the study would be contraindicated.