Company: BIAF
Filing Date: 2025-03-31
Form Type: 10-K
Source: 0001641172-25-001840
Chunk: 12

Company: bioAffinity Technologies, Inc.
Filing Date: 2025-03-31
Form: 10-K
Item: Item 1
Chunk 12
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% 
     87% 
    None 
    “Detection of Early-Stage Lung Cancer in Sputum using Automated Flow Cytometry and Machine Learning,” published in Respiratory Research on January 21, 2023

    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

 11 

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.