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:

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.