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

Company: bioAffinity Technologies, Inc.
Filing Date: 2025-03-31
Form: 10-K
Item: Item 1
Chunk 10
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 from 12 uranium miners. Microscope slides of
sputum samples were labeled with the synthetic fluorescent porphyrin TCPP. The Los Alamos research study of 12 uranium miners included
eight men with cancer and four healthy individuals. Researchers were blinded to the sample origin and looked for the presence of highly
fluorescent cells indicating uptake of TCPP as an indicator of lung cancer. The length of the study and specific follow-up was not reported,
but researchers did report that one patient in the study who had been incorrectly considered to be a healthy subject was correctly
diagnosed with cancer by the test. Later, a blinded clinical trial was conducted and results published September 2015 in an article titled
“Early Detection of Lung Cancer with Meso-Tetra (4-Carboxyphenyl) Porphyrin-Labeled Sputum” in the Journal of Thoracic
Oncology. This study reported on an earlier version of CyPath® Lung that used a fluorescent microscope to directly
identify cells labeled with TCPP in one-third or less of the sputum sample. For each trial participant, researchers manually scanned
12 microscope slides labeled with TCPP for the presence of red fluorescent cells (“RFCs”) displaying a spectral signature
that indicated uptake of TCPP in the cell. In addition to measuring the spectral signature, the fluorescent intensity and cell size of
RFCs were measured. The test data, including fluorescent intensity over cell size, was analyzed. The trial was conducted over 24 months
and resulted in 81% test accuracy, 77.9% sensitivity, and 65.7% specificity in the ability to correctly differentiate between samples
from lung cancer patients and those at high risk who were cancer-free. The earlier trial required participants to provide a sputum sample
and CT imaging of the lungs. Those in the cancer cohort underwent a biopsy to confirm lung cancer. High-risk patients displaying indeterminate
nodules were followed for 18 months to confirm they were cancer-free. The study concluded that optimizing the test to provide for analysis
of the entire sputum sample would improve results.

 10 

On
January 1, 2024, the Medicare reimbursement code 0406U specific for CyPath® Lung became effective after multiple regulatory
decisions in 2023 leading to approval. On June 6, 2023, the American Medical Association (“AMA”) approved a Current Procedural
Terminology (“CPT”) Propri