Company: BIAF
Filing Date: 2025-03-31
Form Type: 10-K
Source: 0001641172-25-001840
Chunk: 11

Company: bioAffinity Technologies, Inc.
Filing Date: 2025-03-31
Form: 10-K
Item: Item 1
Chunk 11
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etary 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.”

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 
    Intended Patient 
    Sensitivity  
    Specificity  
    Procedural Risk 
    Source

    CyPath® Lung‌ 
    High risk 
     82% 
     88% 
    None 
    “Detection of Early-Stage Lung Cancer in Sputum using Automated Flow Cytometry and Machine Learning,” published in Respiratory Research on January 21, 2023

    CyPath® Lung 
    High risk – nodules less than 20 mm 
     92