Company: BIAF
Filing Date: 2025-03-31
Form Type: 10-K
Source: 0001641172-25-001840
Chunk: 8

Company: bioAffinity Technologies, Inc.
Filing Date: 2025-03-31
Form: 10-K
Item: Item 1
Chunk 8
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 Blue has been 510(k)-cleared by the FDA as a positive expiratory pressure device to help mobilize lung secretions in people
with certain lung conditions

The
sputum sample is shipped overnight by the patient to PPLS and processed into a single-cell suspension, then labeled with antibodies that
distinguish different cell types and the synthetic porphyrin TCPP that identifies cancer cells and/or cancer-associated cells. Our test
can collect sample data and analyze a sputum sample in less than 30 minutes using integrated software for high-throughput, user-friendly
standardized analysis. A physician’s report is generated within minutes after data acquisition. The report stratifies the patient
into one of two risk groups. Those patients deemed “likely or very likely” to have cancer may benefit from aggressive intervention.
Those “unlikely or very unlikely” to have a malignancy may continue imaging surveillance in accordance with local standard
of care. The physician’s report also shows a numerical score between 0.1 to 1.0,
with 0.1 to less than 0.5 being a negative result and 0.5 to 1.0 considered positive for lung cancer. The proprietary automated analysis
software was developed and is wholly owned and patent protected by bioAffinity Technologies.

Physicians
receive test results within three days after the laboratory receives the patient’s sputum sample. CyPath® Lung testing
helps identify patients who should undergo more aggressive follow-up procedures to confirm a suspected lung cancer. When CyPath®
Lung sample analysis determines a patient is unlikely or very unlikely to have lung cancer, the result can serve to guide and support
a physician’s decision to monitor the patient using LDCT or CT imaging.

As
reported in an article titled “Detection of Early-Stage Lung Cancer in Sputum using Automated Flow Cytometry and Machine Learning,”
published in Respiratory Research on January 21, 2023, we conducted a 150-patient test validation trial of people at high risk
for lung cancer including patients with the disease (N=28) and those who were cancer-free (N=122) that resulted in CyPath®
Lung’s overall 88% specificity, meaning the ability to correctly identify a person without cancer, and 82% sensitivity, meaning
the ability to correctly identify cancer in a person with the disease. For the subset of patients in this trial who had lung nodules
20 mm or smaller or no nodules