Company: BIAF
Filing Date: 2025-04-11
Form Type: S-1
Source: 0001641172-25-003892
Chunk: 108

Company: bioAffinity Technologies, Inc.
Filing Date: 2025-04-11
Form: S-1
Chunk 108
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 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. CyPathLung uses
automated data analysis developed by machine learning, a form of AI, that allows data collection and analysis of an entire sample of sputum
in less than 30 minutes, allowing for cost-effective, large-scale commercialization.

We conducted a 150-patient test validation trial of
people at high risk for lung cancer including patients with the disease (N=28) and those who were cancer-free (N=122) that resulted in
CyPath Lung’s overall 88% specificity, meaning the ability to correctly identify a person without cancer, and 82%
sensitivity, meaning the ability to correctly identify cancer in a person with the disease. CyPath Lung correctly detected
80% of Stage I lung cancers. The test detected multiple lung cancer types including non-small cell, small cell, adenocarcinoma, squamous,
and large cell cancers. For the subset of patients in this trial who had lung nodules 20 millimeters (“mm”) or smaller, this
trial resulted in 92% sensitivity, 87% specificity, 99% negative predictive value, and 88% accuracy. In this subset of 132 individuals
with small nodules, 119 patients were cancer-free and 13 had confirmed lung cancer. The detection of small lung nodules in people who
have early-stage cancer can increase lung cancer survival.

Current Year Financial Highlights

Key financial results for the year ended December
31, 2024 include:

| ● | Consolidated revenue increased approximately 270% to $9.4 million as compared to $2.5 million for the year ended December 31, 2023, primarily as a result of the acquisition of PPLS in September 2023.                                 |
| ● | CyPath® Lung testing revenue increased approximately 1,400% to $0.5 million as compared to $35 thousand for the year ended