Company: BIAF
Filing Date: 2025-04-11
Form Type: S-1
Source: 0001641172-25-003892
Chunk: 119

Company: bioAffinity Technologies, Inc.
Filing Date: 2025-04-11
Form: S-1
Chunk 119
---
 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, cost-effective, high-performing lung cancer diagnostic that meets the need for more diagnostic certainty leading to quicker diagnosis at earlier stage for longer survival and reduced medical costs. The U.S. Preventive Services Task Force recommended new guidelines for screening in March 2021, nearly doubling the number of Americans at high risk for lung cancer who are recommended for annual screening to 14 million people, according to the ALA. In November 2023, the American Cancer Society updated its guidelines for lung cancer screening to include all former smokers over the age of 50 regardless of when they quit, increasing the estimated number of American adults eligible for screening to 19 million. China has an estimated 300 million smokers, according to the World Health Organization. In Europe, it is estimated