Company: BIAF
Filing Date: 2025-03-31
Form Type: 10-K
Source: 0001641172-25-001840
Chunk: 6

Company: bioAffinity Technologies, Inc.
Filing Date: 2025-03-31
Form: 10-K
Item: Item 1
Chunk 6
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ology and critical care physician and
Assistant Dean of Research at San Antonio Uniformed Services Health Education Consortium (“SAUSHEC”), and Sheila A. Habib,
M.D., Director of the Pulmonary Lung Nodule Clinic and the Lung Cancer Screening Program at the South Texas Veterans Health Care Systems’
Audie L. Murphy Memorial Veterans Hospital and Assistant Professor at the University of Texas Health Science Center at San Antonio, were
first and second authors on the study published in the Journal of Health Economics and Outcomes Research. Economists John E. Schneider,
Ph.D., and Maggie L. Do Valle, Master of Public Health, of Avalon Health Economics also contributed to the study.

CyPath®
Lung uses flow cytometry technology to detect and analyze cell populations in a person’s sputum, or phlegm, to find characteristics
indicative of lung cancer, including cancer and/or cancer-related cells that have shed from a lung tumor. The flow cytometer is a well-established
instrument used in many commercial laboratories. Flow cytometry collects data pertaining to properties of single cells labeled with antibodies
and dyes specific to cell types and characteristics. Sputum is an excellent sample for analysis because it is in direct contact with
any malignancy in the lungs and can provide information about its area of field cancerization and the lung microenvironment.

In
particular, CyPath® Lung uses a synthetic porphyrin called meso-tetra (4-carboxyphenyl) porphyrin (“TCPP”).
Porphyrins are biological pigments that, when exposed to ultraviolet light at certain wavelengths, can result in the cell fluorescing
a red or purplish color that can be detected under a microscope or by flow cytometry, according to an article titled “Laboratory
Diagnosis of Porphyria,” published in Diagnostics (Basel) on July 26, 2021. Porphyrins can be man-made, like TCPP, or they
can be naturally occurring, like heme that is responsible for the red color in red blood cells. Cancer cells are known to take up certain
porphyrins in higher amounts than non-cancer cells, and the high affinity for cancer cells displayed by TCPP makes it an excellent bio-label
for cancer, according to an article published in Progress in Clinical and Biological Research in 1984 titled “A comparative
study of 28 porphyrins and their abilities to localize in mammary mouse carcinoma