Company: BIAF
Filing Date: 2025-03-31
Form Type: 10-K
Source: 0001641172-25-001840
Chunk: 182

Company: bioAffinity Technologies, Inc.
Filing Date: 2025-03-31
Form: 10-K
Item: Item 1A
Chunk 182
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 “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.

 27 

If
we are unable to convince physicians of the benefits of our proposed diagnostic tests or therapeutic products, we may incur delays or
additional expense in our attempt to establish market acceptance.

Broad
use of our proposed diagnostic tests and products may require pathology laboratories and physicians to be informed regarding our proposed
diagnostic tests and products and their intended benefits. Inability to carry out this physician education process may adversely affect
market acceptance of our proposed diagnostic tests or therapeutic products. We may be unable to timely educate physicians regarding our
proposed diagnostic tests or therapeutic products in sufficient numbers to achieve our marketing plans or to achieve acceptance of our
diagnostic tests or therapeutic products. Any delay in physician education may materially delay or reduce demand for our diagnostic tests
or therapeutic products. In addition, we may expend significant funds toward physician education before any acceptance or demand for
our proposed diagnostic tests or therapeutic products is created, if at all.

We
face substantial competition, which may result in others discovering, developing, or commercializing competing diagnostic tests or therapeutic
products before or more successfully than we do.

The
development and commercialization of new diagnostic and therapeutic technologies is highly competitive. We will always face competition
with respect to any diagnostic and therapeutic technology that we may seek to develop or commercialize in the future from major diagnostic
and pharmaceutical companies, LDT laboratories, smaller diagnostic and pharmaceutical companies, and biotechnology companies worldwide.

A
substantial number of the companies against which we are competing or may compete against in the future may have significantly greater
financial resources, established presence in the market, and expertise in research and development, manufacturing, preclinical testing,
conducting clinical trials, obtaining regulatory approvals, and marketing approved diagnostic tests or therapeutic products. Mergers
and acquisitions in the diagnostic, pharmaceutical, and biotechnology industries may result in even more resources being concentrated
among a smaller number of our competitors.

Smaller
and other early-stage companies may also prove to be significant competitors, particularly through collaborative arrangements with large
and established companies. These third parties compete with us in recruiting and retaining qualified scientific, sales, marketing, and
management personnel, establishing clinical trial sites and patient registration for