Company: BIAF
Filing Date: 2025-06-27
Form Type: POS AM
Source: 0001641172-25-016923
Chunk: 96

Company: bioAffinity Technologies, Inc.
Filing Date: 2025-06-27
Form: POS AM
Chunk 96
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 became effective after multiple regulatory decisions in 2023 leading to approval. On June 6, 2023, the American Medical Association (“AMA”) approved a Current Procedural Terminology (“CPT”) Proprietary Laboratory Analysis (“PLA”) code specifically for use with CyPath ®Lung, which was publicly released on June 30, 2023. CyPath ®Lung is on CMS’ clinical laboratory fee schedule. The CPT PLA code assigned to CyPath ®Lung is 0406U with the descriptor “Oncology (lung), flow cytometry, sputum, 5 markers (meso-tetra [4- carboxyphenyl] porphyrin [TCPP], CD206, CD66b, CD3, CD19), algorithm reported as likelihood of lung cancer.”

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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.

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 | % 
 % |