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

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:

• 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;
• 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
• 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.