This is a prospective, multi-center study to evaluate the diagnostic performance characteristics of the AminoIndex™ technology among patients at high risk for developing lung cancer as compared with standard lung cancer screening and diagnostic procedures including low-dose CT, high-dose CT, biopsy and histopathology.

This is a prospective, multi-center study to evaluate the diagnostic performance characteristics of the AminoIndex™ technology among patients at high risk for developing lung cancer as compared with standard lung cancer screening and diagnostic procedures including low-dose CT, high-dose CT, biopsy and histopathology.

The study will enroll patients into one of three arms:

1. patients with lung nodule(s) ≥ 6 mm but ≤ 35 mm that have been biopsied and diagnosed with primary lung cancer who have not yet initiated treatment of any kind for their lung cancer;
2. patients with lung nodule(s) ≥ 6 mm but ≤ 35 mm that have been biopsied and determined to not be cancerous OR that have demonstrated no nodule growth for > 2 years by repeat CT imaging; and
3. patients at high-risk for lung cancer (per NLST guidelines) with no evidence or history of lung cancer (negative LDCT/CT/X-ray).

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.

Study will enroll sufficient subjects to yield a minimum of 60 subjects in Study Group 1, 30 subjects in Study Group 2 and 60 subjects in Study Group 3 - a total of 150 evaluable study subjects who meet all inclusion and exclusion criteria. Eligible subjects will be men and women age ≥ 18 years for Group 1 and 2 and 55 - 79 years inclusive for Group 3. Group 3 study subjects must also meet NLST guidelines of being at high risk for lung cancer: greater than or equal to a 30 pack year smoking history (equivalent of 1 pack per day for 30 or more years) and a current smoker or quit less than 15 years ago.