Company: BIAF
Filing Date: 2025-06-27
Form Type: POS AM
Source: 0001641172-25-016927
Chunk: 116

Company: bioAffinity Technologies, Inc.
Filing Date: 2025-06-27
Form: POS AM
Chunk 116
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 markers (meso-tetra [4- carboxyphenyl] porphyrin [TCPP], CD206, CD66b, CD3, CD19), algorithm reported as likelihood of lung cancer.”

We have an agreement with GO2 Partners to produce patient collection kits and to provide warehousing and distribution services for sending out the kits. Laboratory reagents, supplies, and equipment are commercially available through multiple vendors. Sample processing, labeling, and data collection can be accomplished by a laboratory technician skilled in general laboratory techniques. Data analysis leading to a physician’s report is done 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.

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.

| 65 |

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                                                                                                          |
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