Company: BIAF
Filing Date: 2025-04-11
Form Type: S-1
Source: 0001641172-25-003892
Chunk: 27

Company: bioAffinity Technologies, Inc.
Filing Date: 2025-04-11
Form: S-1
Chunk 27
---
| ● | obtain approval with labeling that includes significant use or distribution restrictions or safety warnings; |
| ● | be subject to additional post-marketing testing requirements; or                                             |
| ● | have the diagnostic test or therapeutic product removed from the market after obtaining marketing approval.  |

Our product and test development costs will increase
if we experience delays in clinical testing or marketing approvals. We do not know whether any of our preclinical studies or clinical
trials will begin as planned, will need to be restructured, or will be completed on schedule or at all. Significant preclinical or clinical
trial delays also could shorten any periods during which we may have the exclusive right to commercialize our diagnostic technology or
allow our competitors to bring diagnostic tests and therapeutic products to market before we do, potentially impairing our ability to
successfully commercialize our diagnostic and therapeutic technologies and harming our business and results of operations.

Risks Related to Our Diagnostic Tests

If our tests do not perform as expected, our operating results, reputation and business will suffer.

Our success depends on the market’s confidence
that PPLS can provide reliable, high-quality clinical testing services. There is no guarantee that the accuracy and reproducibility that
our CAP/CLIA clinical pathology laboratory has demonstrated to date will continue as its test volume increases. We believe that PPLS’
customers are likely to be particularly sensitive to test limitations and errors, including inaccurate test results. As a result, if PPLS
does not perform its diagnostic services as expected, our operating results, reputation and business will suffer. We may be subject to
legal claims arising from such limitations, errors, or inaccuracies.

We may experience difficulties that delay or prevent our development, introduction, or marketing of enhanced or new tests.

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