Collection of Sputum and Labeling for Lung Cancer

This study will be performed at multiple study centers to collect sputum samples from three
cohorts including (1) healthy Participants, (2) individuals at high risk for lung cancer and
(3) individuals who have been diagnosed with lung cancer. Participants in the high risk
cohort will undergo low dose computed tomography (LDCT) scans to confirm they do not have
lung cancer. LDCT scans will be evaluated by a radiologist at each site. Each subject's
sputum specimen will be processed in accordance with individual experimental protocol at the
laboratory of bioAffinity Technologies, Inc. (BA) located at the University of Texas at San
Antonio 1604 main campus in San Antonio, Texas, or at the Research DX laboratory in Irvine,
California.

Once a sample is obtained and delivered to the laboratory, the Assay methodology consists of
chemical dissociation of sputum to produce a single cell suspension sample that is labeled
with antibodies to identify various types of cell populations in the sample. Thereafter,
sputum samples are stained with the cancer detection compound, CyPath® Lung. This compound
has a unique fluorescent spectrum that can be analyzed by a flow cytometer. The flow
cytometric analysis confirms that the sample is from the deep lung and identifies various
cell populations based on characteristics such as cell size, granularity, and antigen
expression. Cancer samples can be distinguished from non-cancer samples by the presence of
highly fluorescent cells labeled by CyPath®. In this manner, CyPath® can identify lung cancer
cells and other distinguishing cells that have been sloughed off in the lungs and coughed up
in the sputum sample, including cancer cells.

Researchers who will be blinded as to the Participant's identity will perform the experiments
that compare the characteristics of samples collected by the alternate sample collection
methods and labeled by CyPath® Lung. In the latter phase of the study, the analytical results
of sputum sample analysis requires that the researchers be blinded to the classification of
the sputum sample and methods of collection.

Findings from the CyPath® Lung Assay will not be used in the diagnosis of Participants or
subsequent treatment decisions.

Inclusion Criteria:

Each subject must meet the following criteria to be enrolled in this study:

- Male or female

- 21 years of age or older

- Willing to provide primary care physician contact information to the investigator and
agree to have medical information released if indicated

- Meet requirements of one of three cohorts in the study:

Healthy Cohort: Current non-smoker who has smoked less than 5 pack-years in his or her
lifetime, and if smoked, quit more than 15 years ago, and has no known lung disease.

High Risk Cohort: Individual aged ≥55-74 who is a current smoker with a smoking history of
at least 30 pack-years, or current non-smoker who has a smoking history of at least 30
pack-years, and quit smoking within the past 15 years.

Cancer Cohort: Individual who has been diagnosed by a physician as highly suspect for
having lung cancer but has not yet undergone a biopsy nor received therapy, and after
providing a sputum sample is confirmed to have lung cancer by biopsy.

Exclusion Criteria:

Participants who meet any of the following criteria will be excluded from the study:

- Severe obstructive lung disease and unable to cough with sufficient exertion to
produce a sputum sample. Participants with lung disease that are able to cough with
sufficient exertion to produce a sputum sample are not excluded from the study

- Angina with minimal exertion

- Pregnancy