Company: BIAF
Filing Date: 2025-03-31
Form Type: 10-K
Source: 0001641172-25-001840
Chunk: 60

Company: bioAffinity Technologies, Inc.
Filing Date: 2025-03-31
Form: 10-K
Item: Item 1
Chunk 60
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 enterprises, including our competitors, to market commercial tests or products based on technology developed at such institutions.
Our competitors may succeed in developing or licensing technologies, tests, and products that are more effective or less costly than
ours or succeed in obtaining CAP/CLIA validation or FDA or other regulatory approvals for diagnostic test and therapeutic product candidates
before we do. Acquisitions of, or investments in, competing diagnostic, pharmaceutical, or biotechnology companies by large corporations
could increase such competitors’ financial, marketing, manufacturing, and other resources.

 31 

The
market for our proposed tests and products is competitive and rapidly changing, and new diagnostic technologies which may be developed
by others could impair our ability to maintain and grow our business and remain competitive.

The
diagnostic, pharmaceutical, and biotechnology industries are subject to rapid and substantial technological change. Developments by others
may render our proposed tests or products noncompetitive or obsolete, or we may be unable to keep pace with technological developments
or other market factors. Technological competition from diagnostic, pharmaceutical and biotechnology companies, universities, governmental
entities, and others diversifying into the field is intense and is expected to increase.

As
a company engaged in the development of diagnostic technology with limited revenue generated to date, our resources are limited, and
we may experience technical challenges inherent in such technologies. Competitors have developed or are in the process of developing
technologies that are, or in the future may be, the basis for competition. Some of these technologies may have an entirely different
approach or means of accomplishing similar diagnostic efficacy compared to our proposed tests or products. Our competitors may develop
diagnostic technologies that are more effective or less costly than our proposed tests or products and therefore present a serious competitive
threat.

The
potential widespread acceptance of diagnostic tests or therapies that are alternatives to ours may limit market acceptance of our proposed
tests or products, even if commercialized. Many of our targeted diseases and conditions can also be detected by other tests or treated
by other medications. These tests and treatments may be widely accepted in medical communities and have a longer history of use. The
established use of these competitive technologies may limit the potential for our technologies, formulations, tests, and products to
receive widespread acceptance if commercialized.

Healthcare
cost containment initiatives and the growth of managed care may limit our returns.

Our
ability to commercialize our diagnostic tests and therapeutic products successfully may be affected by the ongoing efforts of governmental
and third-party payors to contain the