Company: BIAF
Filing Date: 2025-04-22
Form Type: 424B3
Source: 0001641172-25-005598
Chunk: 116

Company: bioAffinity Technologies, Inc.
Filing Date: 2025-04-22
Form: 424B3
Chunk 116
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|:----|:-----------------------------------|:----|:------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Low-dose CT screening        |     | High risk                                 |     |             | 94 | % |     |             | 73 | % |     | Radiation exposure                 |     | “Results of initial low dose computed tomographic screening for lung cancer,” published in the New England Journal of Medicine on May 23, 2013              |
| FDG PET imaging              |     | Suspicious lung nodules                   |     |             | 89 | % |     |             | 75 | % |     | Radiation exposure                 |     | “Accuracy of FDG-PET to diagnose lung cancer in areas with infectious lung disease: a meta-analysis,” published in JAMA in September 2014                   |
| Bronchoscopy                 |     | Suspicious lung nodules – central lesions |     |             | 88 | % |     |             | 47 | % |     | Invasive; risk of                  
 collapsed/bleeding lung; infection |     | “A bronchial genomic classifier for the diagnostic evaluation of lung cancer,” published in the New England Journal of Medicine on July 16, 2015            |
| Fine needle biopsy           |     | Suspicious lung nodules                   |     |             | 90 | % |     |             | 75 | % |     | Invasive; risk of                  
 collapsed/bleeding lung; infection |     | “Fine-needle aspiration biopsy versus core-needle biopsy in diagnosing lung cancer: a systemic review,” published in Current Oncology in February 2012      |
| Core needle biopsy21         |     | Suspicious lung nodules                   |     |             | 89 | % |     |             | 89 | % |     | Invasive; risk of                  
 collapsed/bleeding lung; infection |     | “Global patterns and trends in lung cancer incidence: a population-based study,” published in the Journal of Thoracic Oncology on February 16, 2021         |

As seen in the above table, CyPath ®Lung performs similar to current Standard of Care, including more invasive and riskier diagnostic procedures. Moreover, lung nodules are commonly found on CT scans. Studies suggest up to 50% of lung nodules may be considered “indeterminate” without clear indication of being benign or malignant, posing difficult choices for physicians and their patients on steps. Our business model is to address the need for a noninvasive,