Company: BIAF
Filing Date: 2025-04-22
Form Type: 424B3
Source: 0001641172-25-005598
Chunk: 24

Company: bioAffinity Technologies, Inc.
Filing Date: 2025-04-22
Form: 424B3
Chunk 24
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Our success may also depend on our ability to effectively
introduce enhanced or new tests. The development of enhanced or new tests is complex, costly, and uncertain. Furthermore, enhancing or
developing new tests requires us to anticipate patients’, clinicians’, and payors’ needs and emerging technology trends
accurately. We may experience research and development, regulatory, marketing, and other difficulties that could delay or prevent our
introduction of enhanced or new tests. The research and development process in diagnostics generally takes a significant amount of time
from the research and design stage to commercialization. This process is conducted in various stages, and each stage presents the risk
that we will not achieve our goals. We may have to abandon a test in which we have invested substantial resources. In order to successfully
commercialize tests that we may develop in the future, we may need to conduct lengthy, expensive clinical trials and develop dedicated
sales and marketing operations or enter into collaborative agreements to achieve market awareness and demand. Any delay in the research
and development, approval, production, marketing, or distribution of enhanced or new tests could adversely affect our competitive position,
branding, and results of operations.

We cannot be certain that:

| ● | any tests that we may enhance or develop will prove to be effective in clinical trials;   |
| ● | we will be able to obtain, in a timely manner or at all, regulatory approvals, if needed; |

| ● | any tests that we may enhance or develop will be ordered and used by healthcare providers;                   |
| ● | any tests that we may enhance or develop can be provided at acceptable cost and with appropriate quality; or |
| ● | any of our tests can be successfully marketed.                                                               |

These factors and other factors beyond our control
could delay the launch of enhanced or new tests.

| 12 |

If clinical testing of a particular diagnostic test or therapeutic product candidate does not yield successful results, we will be unable to commercialize that test or product candidate.

We must demonstrate the product safety and efficacy
of our candidates for diagnostic tests and therapeutic products in humans through extensive clinical testing. Our research and development
programs are at an early stage of development. We may experience numerous unforeseen events during, or as a result of, the testing process
that could delay or prevent commercialization of any test or product, including the following:

| ● | the results of pre-clinical studies may be inconclusive, or they may not be indicative of results that will be obtained in human clinical