Company: BIAF
Filing Date: 2025-04-22
Form Type: 424B3
Source: 0001641172-25-005598
Chunk: 26

Company: bioAffinity Technologies, Inc.
Filing Date: 2025-04-22
Form: 424B3
Chunk 26
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 and overcome these and
similar concerns, our business and results of operations could be substantially harmed.

If we are unable to establish effective sales, marketing, and distribution capabilities or enter into agreements with third parties with such capabilities, we may not be successful in commercializing our diagnostic tests or therapeutic products if and when they are approved.

We are building our sales and marketing organizations
and have limited experience in the sale, marketing, or distribution 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.

| 13 |

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 pathology laboratory PPLS to offer and perform CyPath ®Lung.

PPLS is currently the only commercial laboratory offering
CyPath Lung and, therefore we are dependent upon our subsidiary PPLS for the generation of our revenue. PPLS performs
testing when ordered by physicians for their patients. PPLS also generates revenue related to the use of CyPath Lung tests
for a DOD observational study titled “Detection of Abnormal Respiratory Cell Populations in Lung Cancer Screening Patients Using
the CyPath Lung Assay,” and when performed for DOD 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