Company: BIAF
Filing Date: 2025-05-02
Form Type: S-1
Source: 0001641172-25-008170
Chunk: 111

Company: bioAffinity Technologies, Inc.
Filing Date: 2025-05-02
Form: S-1
Chunk 111
---
 by automated analysis software fully integrated into the test.

To our knowledge, CyPath ®Lung is the first cancer diagnostic that combines flow cytometry and automated analysis to predict the presence of lung cancer from sputum samples.

| 51 |

The Cancer Diagnostics Market and CyPath ®Lung

The global lung cancer diagnostic market is projected to grow from an estimated $15.1 billion in 2023 to $34.8 billion by the end of 2034, with a compound annual growth rate (“CAGR”) of 7.9%, according to a market research report issued by Transparency Market Research in October 2024. Our Company has the potential to play a significant role in the global cancer diagnostic market because we hold a strong and expanding IP portfolio for CyPath ®Lung, a noninvasive, cost-effective, and high performing test that has the potential to better patient outcomes.

Comparison of CyPath ®Lung to Current Standards of Care

| Diagnostic Test       
 or Procedure          
 CyPath®               
 Lung                  
 CyPath® Lung          |     | Intended                  
 Patient                   
 High risk                 
 High risk – nodules       
 less than 20 mm           |     | Sensitivity | 82 
 92 | % 
 % |     | Specificity | 88 
 87 | % 
 % |     | Procedural Risk                            
 None                                       
 None                                       |     | Source                                                                                                                       
 “Detection                                                                                                                   
 of Early-Stage Lung Cancer in Sputum using Automated Flow Cytometry and Machine Learning,” published in Respiratory Research 
 on January 21, 2023                                                                                                          
 “Detection of Early-Stage                                                                                                    
 Lung Cancer in Sputum using Automated Flow Cytometry and Machine Learning,” published in Respiratory Research on January     
 21, 2023                                                                                                                     |
|:----------------------|:----|:--------------------------|:----|:------------|---:|:--|:----|:------------|---:|:--|:----|:-------------------------------------------|:----|:-----------------------------------------------------------------------------------------------------------------------------|
| Low-dose CT screening |     | High risk                 |     |             | 94 | % |     |             | 73 | % |     | Radiation exposure                         |     | “Results of initial                                                                                                          
 low dose computed tomographic screening for lung cancer,” published in the New England Journal of Medicine on May 23,        
 2013                                                                                                                         |
| FDG PET imaging       |     | Suspicious lung nodules