Company: BIAF
Filing Date: 2025-04-11
Form Type: S-1
Source: 0001641172-25-003892
Chunk: 118

Company: bioAffinity Technologies, Inc.
Filing Date: 2025-04-11
Form: S-1
Chunk 118
---
 analysis to predict the presence of lung cancer from sputum samples.

| 54 |

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                   |     |             | 89 | % |     |             | 75 | % |     | Radiation exposure                 |     | “Accuracy of FDG-PET to diagnose lung cancer in areas with infectious lung disease: a meta-analysis,” published