Company: BIAF
Filing Date: 2025-06-27
Form Type: POS AM
Source: 0001641172-25-016923
Chunk: 100

Company: bioAffinity Technologies, Inc.
Filing Date: 2025-06-27
Form: POS AM
Chunk 100
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 expand our collaboration with regional and national key opinion leaders (“KOLs”) and support efforts with collateral materials, including posters, presentations, videos, and peer-reviewed papers, to our KOLs who will present data and case studies of their use of CyPath ®Lung. This content can be shared across platforms, including websites and sales tools, and will be used as references to support our product claims as well as sales and marketing efforts to physicians, reference laboratories, and patients. We are also working with lung cancer advocacy groups throughout all phases to support the message that routine lung cancer screening can save lives by diagnosing cancer at an early stage.

The Competition for CyPath ®Lung

CyPath ®Lung has not been tested directly against its competitors’ products, but a comparison of the published performance numbers suggests CyPath ®Lung is among the highest performing tests on the market. Furthermore, CyPath ®Lung is noninvasive – not even requiring a needle stick – and cost effective, and processing and analysis procedures are easy to perform.

Published data and the results of clinical trials allow us to group lung cancer diagnostic tests into three categories: (1) balanced tests; (2) rule-out tests, and (3) rule-in tests. Balanced tests aim at excluding patients without cancer from unnecessary follow-up diagnostic procedures and detecting patients with early-stage cancer who can proceed to more aggressive procedures to confirm diagnosis. Rule-out tests aim to exclude patients without cancer from unnecessary follow-up procedures with high accuracy (if the test provides a “negative” result), but among the remainder of patients who do not receive an unambiguous negative result, there is still uncertainty about who has cancer and who does not. Cancer patients for whom time is of the essence are included in this group of patients still in uncertainty. The patient can lose precious time with a rule-out test. Rule-in tests aim to identify patients with cancer but in doing so may identify many people without cancer as positive. Therefore, rule-in tests have a low positive predictive value.

The recent economic journal article evaluating the significant healthcare cost benefits of using CyPath ®Lung as a standard of care (Morris, et al., 2024) shows that balanced tests, like CyPath ®Lung, can be the most cost effective. Those that perform well are most useful to a physician and his or her patient because they provide the most information, allowing a quicker decision on what follow-up path to choose: whether to move forward with more aggressive follow-up procedures (i.e., in the case