Company: BIAF
Filing Date: 2025-03-31
Form Type: 10-K
Source: 0001641172-25-001840
Chunk: 19

Company: bioAffinity Technologies, Inc.
Filing Date: 2025-03-31
Form: 10-K
Item: Item 1
Chunk 19
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ancerous 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.

 13 

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 EU have been diagnosed with asthma; and 4.2% of Chinese
adults presented with asthma in a representative sample of adults recruited for a national cross-sectional China Pulmonary Health study
between 2012 and 2015, representing 45.7 million adults in China. Furthermore, an estimated 14.2 million U.S. adults had COPD in 2021
and approximately 36.6 million people in