Company: BIAF
Filing Date: 2025-05-02
Form Type: S-1
Source: 0001641172-25-008170
Chunk: 101

Company: bioAffinity Technologies, Inc.
Filing Date: 2025-05-02
Form: S-1
Chunk 101
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-up procedures and those who are likely without lung cancer and should continue routine screening. CyPath ®Lung has the potential to increase overall diagnostic accuracy of lung cancer, which could lead to increased survival, fewer unnecessary invasive procedures, reduced patient anxiety, and lower medical costs.

CyPath ®Lung uses flow cytometry technology to detect and analyze cell populations in a person’s sputum, or phlegm, to find characteristics indicative of lung cancer, including cancer and/or cancer-related cells that have shed from a lung tumor. The flow cytometer is a well-established instrument used in many commercial laboratories. Flow cytometry collects data pertaining to properties of single cells labeled with antibodies and dyes specific to cell types and characteristics. Sputum is an excellent sample for analysis because it is in direct contact with any malignancy in the lungs and can provide information about its area of field cancerization and the lung microenvironment. CyPath ®Lung uses automated data analysis developed by machine learning, a form of AI, that allows data collection and analysis of an entire sample of sputum in less than 30 minutes, allowing for cost-effective, large-scale commercialization.

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. CyPath ®Lung correctly detected 80% of Stage I lung cancers. The test detected multiple lung cancer types including non-small cell, small cell, adenocarcinoma, squamous, and large cell cancers. For the subset of patients in this trial who had lung nodules 20 millimeters (“mm”) or smaller, this trial resulted in 92% sensitivity, 87% specificity, 99% negative predictive value, and 88% accuracy. In this subset of 132 individuals with small nodules, 119 patients were cancer-free and 13 had confirmed lung cancer. The detection of small lung nodules in people who have early-stage cancer can increase lung cancer survival.

Current Year Financial Highlights

Key financial results for the year ended December 31, 2024 include:

| ● | Consolidated                                                                                                                     
 revenue increased approximately 270% to $9.4 million as compared to $2.5 million for the year