Company: BIAF
Filing Date: 2025-06-27
Form Type: POS AM
Source: 0001641172-25-016927
Chunk: 107

Company: bioAffinity Technologies, Inc.
Filing Date: 2025-06-27
Form: POS AM
Chunk 107
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 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. CyPath ®Lung 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 three months quarter ended March 31, 2025, include:

| ● | Consolidated                                                                                                                            
 revenue decreased approximately 23% to $1.9 million as compared to $2.4 million for the three months ended March 31, 2024, primarily    
 as a result of our targeted strategic actions to discontinue certain unprofitable pathology services, reduced costs through operational 
 efficiency and drive sales growth for CyPath® Lung.                                                                                     |
| ● | CyPath®                                                                                                                                 
 Lung testing revenue increased approximately 275% to $169,000 as compared to $45,000 for the three months ended March 31, 2024, due     
 to an increase in total test results delivered of approximately 200 for the current quarter