Company: BIAF
Filing Date: 2025-10-09
Form Type: 424B5
Source: 0001493152-25-017591
Chunk: 39

Company: bioAffinity Technologies, Inc.
Filing Date: 2025-10-09
Form: 424B5
Chunk 39
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 of our diagnostic tests and therapeutic products. To achieve commercial success for any diagnostic test or therapeutic product for which we obtain marketing approval, we will need to successfully establish and maintain relationships directly and with third parties to perform sales and marketing functions.

Factors that may inhibit our efforts to commercialize our diagnostic tests or therapeutic products on our own include:

| ● | our                                                                                                                                     
 inability to recruit, train, and retain adequate numbers of effective sales, technical support, and marketing personnel;                |
| ● | the                                                                                                                                     
 inability of sales personnel to obtain access to or educate physicians on the benefits of our diagnostic tests or therapeutic products; |
| ● | the                                                                                                                                     
 lack of complementary diagnostic tests or therapeutic products to be offered by sales personnel, which may put us at a competitive      
 disadvantage relative to companies with more extensive diagnostic tests or therapeutic product lines;                                   |
| ● | unforeseen                                                                                                                              
 costs and expenses associated with creating an independent sales, technical support, and marketing organization; and                    |
| ● | the                                                                                                                                     
 inability to obtain sufficient coverage and reimbursement from third-party payors and governmental agencies.                            |

If we do not establish sales, marketing, and distribution capabilities successfully, either on our own or in collaboration with third parties, we will not be successful in commercializing our diagnostic tests or therapeutic products.

We are currently dependent upon our subsidiary, PPLS, for processing and sale of CyPath ®Lung.

PPLS, our subsidiary, is currently the only licensee of CyPath ®Lung and, therefore, we are dependent upon the efforts of PPLS, a CAP/CLIA clinical laboratory that is authorized to offer and perform our CyPath ®Lung test for the generation of revenue. Revenue from CyPath Lung is generated through performance of testing by PPLS. PPLS performs testing when ordered by physicians for their patients. PPLS also generates revenue when performed in the context of an observational study conducted by the Department of Defense (the “DOD”) titled “Detection of Abnormal Respiratory Cell Populations in Lung Cancer Screening Patients Using the CyPath ®Lung Assay,” and when performedfor research and development on using bronchoalveolar lavage fluid as a biological sample to assess cardiopulmonary function and exercise performance in military personnel post COVID-19 infection.

If we are unable to convince physicians of the benefits of our proposed diagnostic tests or therapeutic products, we may incur delays or additional expense in our attempt to establish market acceptance.

Broad use of our proposed diagnostic tests and products may require