Company: BIAF
Filing Date: 2025-06-27
Form Type: POS AM
Source: 0001641172-25-016923
Chunk: 103

Company: bioAffinity Technologies, Inc.
Filing Date: 2025-06-27
Form: POS AM
Chunk 103
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, in nearly half of the patients who received the Percepta nasal swab test, the results would not help advance the diagnostic process. In fact, for those patients in this indeterminate category who dohave cancer, valuable time in diagnosis may be lost.

We believe there are many reasons why CyPath ®Lung is a superior test when compared to its competitors. First, lung sputum is an excellent medium for early lung cancer detection because sputum is in close contact with the tumor and pre-cancerous areas that shed cancer and pre-cancerous cells directly into the sputum, can be obtained noninvasively, and can be transported easily. Moreover, sputum contains immune cell populations in reaction to the presence of a tumor. Second, our proprietary technology is straightforward. Our CyPath ®Lung platform technology is not a molecular test and does not collect genetic material that requires immediate processing. CyPath ®Lung uses well-established flow cytometry techniques to investigate cells contained in the sputum for characteristics that indicate the likelihood of lung cancer. Sample processing is straightforward, and laboratory technicians can be easily trained. Reagents used by the test are widely available. Data acquisition and analysis is fully automated, allowing for non-biased, efficient test results. Third, CyPath ®Lung has shown high specificity and sensitivity that is similar to far more invasive and more expensive procedures currently used to detect lung cancer. Fourth, CyPath ®Lung is cost effective, with a Medicare reimbursement code billable to both government and private insurance carriers. A 2024 study authored by Michael Morris, M.D., and Sheila Habib, M.D., reported on CyPath ®Lung’s economic impact when used as companion test to the current Standard of Care predicting savings of more than $2,700 per Medicare patient and more than $6,400 per patient with private payer insurance who have pulmonary nodules sized less than 30 mm. Fifth and as important as any of our test’s benefits, CyPath ®Lung is patient friendly, providing at-home, noninvasive sample collection.

Building on our Flow Cytometry Platform to Develop COPD and asthma precision diagnostics

We are conducting research to expand our platform technology to detect other lung diseases, including development of precision diagnostics to identify patients who can best use commercial therapies and treatments in late-stage clinical phases that treat asthma and Chronic Obstruction Pulmonary Disease (COPD).

An estimated 23 million adults in the U.S. and 27 million people in the