Company: BIAF
Filing Date: 2025-04-22
Form Type: 424B3
Source: 0001641172-25-005598
Chunk: 105

Company: bioAffinity Technologies, Inc.
Filing Date: 2025-04-22
Form: 424B3
Chunk 105
---
 diagnostic test, CyPath
Lung, addresses the need for noninvasive detection of early-stage lung cancer. Lung cancer is the leading cause of cancer-related deaths
worldwide. Physicians order CyPath Lung to assist in their assessment and care of patients who are at high risk for lung
cancer. The CyPath Lung test enables physicians to more confidently identify patients who will likely benefit from timely
intervention and more invasive follow-up procedures and those who are likely without lung cancer and should continue routine screening.
CyPath Lung has the potential to increase overall diagnostic accuracy of lung cancer, which could lead to increased survival,
fewer unnecessary invasive procedures, reduced patient anxiety, and lower medical costs.

CyPathLung 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. 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