Company: BIAF
Filing Date: 2025-04-22
Form Type: 424B3
Source: 0001641172-25-005598
Chunk: 120

Company: bioAffinity Technologies, Inc.
Filing Date: 2025-04-22
Form: 424B3
Chunk 120
---
 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 of CyPath ®Lung, if the test reveals a “likely” or “highly likely” cancer result) or to follow a more conservative approach (i.e., when the CyPath ®Lung test reveals an “unlikely” or “very unlikely” cancer result).

Our competitive analysis reviewed published research that was sufficient to provide a scientific basis for evaluation. We found only seven tests, including CyPath ®Lung, that represent a balanced test for early lung cancer detection and have advanced to the point that there is sufficient data for evaluation. One test is sold by two companies: one from the U.S. and one from China. In the U.S., the test is called Lung LB (sold by LungLife AI) and is now on the market. LungLB is a FISH-based test that requires