Company: BIAF
Filing Date: 2025-03-31
Form Type: 10-K
Source: 0001641172-25-001840
Chunk: 49

Company: bioAffinity Technologies, Inc.
Filing Date: 2025-03-31
Form: 10-K
Item: Item 1
Chunk 49
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 these trials or tests are not positive or are only modestly
positive, or if there are safety concerns, we may:

    ●
    be
    delayed in obtaining marketing approval;

    ●
    not
    obtain marketing approval at all, which would seriously impair our viability;

 25 

    ●
    obtain
    marketing approval in some countries and not in others;

    ●
    obtain
    approval for indications or patient populations that are not as broad as we intend or desire;

    ●
    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