Company: BIAF
Filing Date: 2025-04-11
Form Type: S-1
Source: 0001641172-25-003892
Chunk: 111

Company: bioAffinity Technologies, Inc.
Filing Date: 2025-04-11
Form: S-1
Chunk 111
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-related deaths worldwide, claiming more than 1.8 million lives with almost 2.5 million new cases reported
in 2022 according to a 2024 article in CA: A Cancer Journal for Clinicians. Cancer Epidemiology reports that lung cancer is the
leading cause of cancer deaths in the European Union with an estimated 17 to 34 million people at high risk. China reported 1,060,600
new cases of lung cancer in 2022. According to the American Lung Association (“ALA”), screening for individuals at high risk
for lung cancer has the potential to improve lung cancer survival rates by finding disease at an earlier stage when it is more likely
to be curable. An estimated 19.3 million Americans should have annual screening for lung cancer, according to American Cancer Society
recommendations. A study published in the New England Journal of Medicine titled “Survival of patients with stage I lung
cancer detected on CT screening” dated October 26, 2006, reported that the survival rate of individuals with Stage I lung cancer
who underwent surgical resection within one month after diagnosis had a ten-year survival rate of 92%, as compared to the overall five-year
survival rate in the U.S. of 28.4% as reported by the ALA in its 2024 “State of Lung Cancer” report. Unfortunately, most lung
cancer is detected in late stages. The results of a large national clinical trial that was reported in the New England Journal of Medicine
in an article dated August 4, 2011, titled “Reduced Lung-Cancer Mortality with Low-Dose Computed Tomographic Screening” showed
that screening for lung cancer using low-dose computed tomography (“LDCT”) resulted in a reduction of the mortality rate by
up to 20% as compared to screening by X-ray if LDCT screening is used by patients at high risk for lung cancer on an annual basis. Therefore,
LDCT scans are recommended for screening of an estimated 14 million Americans who are at high risk for lung cancer. If half of these high-risk
individuals were screened, more than 12,000 lung cancer deaths could be prevented, according to the ALA. However, the New England Journal of Medicine article also reported that LDCT was shown to have a low positive predictive value of less than 4%. This means that for
every 100 people who receive a positive result from LDCT screening and are suspected of having lung cancer