Sputum Labeling Utilizing Synthetic Meso-Tetra (4-Carboxyphenyl) Porphyrin (TCPP) for Detection of Lung Cancer

A clinical study was completed to determine the clinical sensitivity and specificity of the
CyPath® Early Lung Cancer Detection Assay (the "Assay") by comparing sputum specimens from
three cohorts of Participants including healthy individuals, individuals at high risk for
lung cancer and individuals diagnosed with lung cancer. Results were published in the Journal
of Thoracic Oncology- see reference. Research now is planned to optimize the Assay as
described below. Therefore, collection and analysis of sputum samples from three cohorts
including healthy Participants, high risk Participants and cancer patient Participants are
needed to conduct continuing research leading to optimization of the Assay.

This study will be performed at multiple study centers to collect sputum samples from three
cohorts including healthy Participants who have no known lung disease, individuals at high
risk for lung cancer and individuals at high risk for lung cancer who have been diagnosed
with lung cancer. The sputum samples will be collected at the study site or at the
Participant's home after explanation of the collection procedure by study staff. Samples will
be identified with an identification number blinding the sample identity. However, the cohort
classification of the sputum sample will be known by the Researcher as required to conduct
the experiments. In the latter phase of the study that requires comparison of results between
cohorts, researchers will be blinded to the classification of the sputum sample. 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. The BA laboratory will
process each sputum sample for use in optimizing the Assay. bioAffinity researchers who will
be blinded as to the Participant's identity will perform the experiments that will determine
methods to liquefy sputum, select proper fixatives and buffers, determine the efficacy of use
of methyl-beta-cyclodextrin (MBCD) in sputum processing and determine the cell count in
sputum, as described below. In the latter phase of the study, the analytical results of
sputum sample analysis requires that the researchers will be blinded to the classification of
the sputum sample. To ensure sample adequacy as it relates to its collection for the deep
lung, samples will be analyzed by a cytologist who will perform PAP staining for the presence
of macrophages. Macrophages are an indication that the sputum sample is from deep within the
lungs. Findings of the experiments and comparative study will not be used in the diagnosis or
treatment of Participants.

Later optimization efforts including the comparative study will require that participants in
the high-risk cohort undergo low dose computed tomography (LDCT) scans to confirm they do not
have lung cancer. LDCT scans will be evaluated by a licensed, independent radiologist who may
advise the participant to seek additional medical advice if warranted by LDCT imaging.
Participants in the cancer cohort will have undergone LDCT scans identifying them as likely
to have lung cancer prior to sample collection. Findings from the CyPath® Early Lung Cancer
Detection 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

- Study Participants must be willing to provide primary care physician contact
information 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, has quit for more than 15 years ago and who has
no known lung disease.

- High Risk Cohort: Current smoker, or individual who has quit smoking less than 15
years before study start, who has smoked more than 30 pack-years in his or her
lifetime.

- Cancer Cohort: Individual who has been diagnosed by a physician with lung cancer.

Exclusion Criteria:

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

- Lung disease

- Angina with minimal exertion

- Pregnancy

- Have or have had cancer other than lung cancer

- Worked in the mining Industry