Company: BIAF
Filing Date: 2025-03-31
Form Type: 10-K
Source: 0001641172-25-001840
Chunk: 13

Company: bioAffinity Technologies, Inc.
Filing Date: 2025-03-31
Form: 10-K
Item: Item 1
Chunk 13
---
 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 that there is one new case of lung cancer diagnosed
every minute, with incidence rates for males the highest in Eastern European countries and a five-year survival rate of only 13%, as
reported by a May 2021 article, “Lung cancer screening in Europe: where are we in 2021?” published in Translational Lung
Cancer Research. We expect to pursue CE marking of CyPath® Lung for sale in the European Union (“EU”).

CyPath®
Lung Business Development Plan

We
believe in the viability of our business plan based on the circumstances surrounding our business that are known to us as of the date
of this Annual Report. However, the timing, strategies, and stages of our business plan may evolve in light of new circumstances that
cannot be predicted with certainty at this time. Our business plan envisions four phases of expanding market entry into the U.S., the
EU, and worldwide that are timed to maximize our resources and minimize market risk. Phase 1 of our business plan was completed in 2024
with a limited market launch of our LDT CyPath® Lung in Texas. This limited test market launch was designed to evaluate
our marketing program and help us ensure each step in the care pathway – from the initial order by physicians to sputum collection
and processing, to generating and delivering the patient report – is efficient and effective. This limited test market approach
allowed us to refine future positioning and develop strategic insight for our CyPath® Lung test before expanding to a
larger market.

We
believe that our strategy related to a limited market launch proved successful. In January 2025, we reported the results of the
Company’s CyPath® Lung pilot marketing program using Texas for our beta launch with sales growth
Quarter-over-Quarter and more than 600 tests delivered in 2024. We attribute the growth in sales to