Company: BIAF
Filing Date: 2025-08-14
Form Type: 10-Q
Source: 0001641172-25-024163
Chunk: 56

Company: bioAffinity Technologies, Inc.
Filing Date: 2025-08-14
Form: 10-Q
Item: Part I, Item 8
Chunk 56
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these activities. We may never succeed in these activities and, even if we do, may never generate sufficient income to achieve profitability.

To
become profitable, we must develop our diagnostic tests and therapeutic products, which will depend in large part on our ability to:

    ●
    Develop, enhance, and protect
    our diagnostic tests and therapeutic products;

    ●
    Raise sufficient funding
    to support our diagnostic tests and therapeutic product development program(s);

    ●
    Complete pre-clinical testing
    of new diagnostic and therapeutic products;

29

    ●
    Expand commercialization
    of CyPath® Lung as an LDT under the CAP/CLIA guidelines and regulations administered by CMS and CAP and/or, if and
    when we obtain clearance from FDA for our CyPath® Lung test, to expand sales in accordance with FDA rules and regulations.

    ●
    Develop and commercialize
    CyPath® Lung as a CE-marked test in accordance with the In Vitro Diagnostic Regulation (“IVDR”) of the
    European Union (“EU”);

    ●
    Conduct research studies
    resulting in scientific results required to successfully develop therapeutic products based on our discoveries that the knockdown
    of certain cell receptors results in cancer death without harm to healthy tissue;

    ●
    Develop and conduct human
    clinical studies to support the regulatory approval and marketing of our diagnostic test(s) and therapeutic product(s);

    ●
    Develop and manufacture
    the test(s) and product(s) to FDA standards, appropriate EU standards, and appropriate standards required for the commercialization
    of our tests and products in countries in which we seek to sell our diagnostic test(s) and therapeutic product(s);

    ●
    Obtain the necessary regulatory
    approvals to market our diagnostic test(s) and therapeutic product(s);

    ●
    Secure the necessary personnel
    and infrastructure to support the development, commercialization, and marketing of our diagnostic test(s) and therapeutic product(s);
    and

    ●
    Develop strategic relationships
    to support development, manufacturing, and marketing of our diagnostic test(s) and therapeutic product(s).

Even
if we do achieve profitability, we may not be able to sustain or increase profitability on a quarterly or annual basis. Our failure to
become and remain profitable would depress our value and could impair our ability to raise capital, expand our business, maintain the
research and development efforts, diversify our diagnostic tests and therapeutic product offerings, or even continue