Company: BIAF
Filing Date: 2025-03-31
Form Type: 10-K
Source: 0001641172-25-001840
Chunk: 61

Company: bioAffinity Technologies, Inc.
Filing Date: 2025-03-31
Form: 10-K
Item: Item 1
Chunk 61
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 cost of healthcare. These entities are challenging prices of healthcare products and services,
denying or limiting coverage and reimbursement amounts for new diagnostic tests and therapeutic products, CAP/CLIA-validated LDTs, and
FDA-approved diagnostic tests and therapeutic products considered experimental or investigational or which are used for disease indications
without FDA marketing authorization. Even if we succeed in bringing any tests or products to the market, they may not be considered cost
effective, and governmental or third-party reimbursement might not be available or sufficient. If adequate governmental or third-party
coverage is not available, we may not be able to maintain price levels sufficient to realize an appropriate return on our investment
in research and development for new tests and products. In addition, legislation and regulations affecting the pricing of diagnostic
tests, pharmaceuticals, or healthcare services may change in ways adverse to us before or after any of our proposed tests and products
are approved for marketing.

Our
internal information technology systems, or those of our third-party clinical research organizations or other contractors or consultants,
may fail or suffer security breaches, loss or leakage of data, and other disruptions, which could result in a material disruption of
our diagnostic tests’ or therapeutic product candidates’ development programs, compromise sensitive information related to
our business, or prevent us from accessing critical information, potentially exposing us to liability or otherwise adversely affecting
our business.

We
are increasingly dependent upon information technology systems, infrastructure, and data to operate our business. In the ordinary course
of business, we collect, store, and transmit confidential information (including but not limited to intellectual property, proprietary
business information, and personal information). It is critical that we do so in a secure manner to maintain the confidentiality and
integrity of such confidential information. We have also outsourced elements of our operations to third parties, and as a result we manage
a number of third-party contractors who have access to our confidential information.

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Despite
the implementation of security measures, given their size and complexity and the increasing amounts of confidential information that
they maintain, our internal information technology systems and those of our third-party clinical research organizations and other contractors
and consultants are potentially vulnerable to breakdown or other damage or interruption from service interruptions, system malfunction,
natural disasters, terrorism, war, and telecommunication and electrical failures, as well as security breaches from inadvertent or intentional
actions by our employees, contractors, consultants, business partners, and/or other third parties, or from cyberattacks by malicious
third parties (including the deployment