Company: BIAF
Filing Date: 2025-03-31
Form Type: 10-K
Source: 0001641172-25-001840
Chunk: 9

Company: bioAffinity Technologies, Inc.
Filing Date: 2025-03-31
Form: 10-K
Item: Item 1
Chunk 9
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 detected by imaging, this trial resulted in 92% sensitivity, 87% specificity, 99% negative predictive
value, and 88% accuracy. In this subset of 132 individuals with small nodules, 119 patients were cancer-free and 13 had confirmed lung
cancer. Eight out of 10 (80%) of Stage I tumors were correctly identified. Sensitivity is the percentage of persons with the disease
– in this case, lung cancer – who are correctly identified by the test. Specificity is the percentage of persons without
lung cancer who are correctly identified by the test. The cancer group included all lung cancer types, but mostly squamous cell carcinoma
and adenocarcinoma lung cancer (in near equal numbers), showing that CyPath® Lung detects all types of lung cancer. Furthermore,
clinical trial results reported an Area Under the Curve (AUC) value of 0.89 for CyPath® Lung. AUC value indicates the
ability of a test to distinguish between positive and negative cases. An AUC value of 0.7 to 0.8 is considered acceptable; 0.8 to 0.9
is excellent; more than 0.9 is outstanding. In study participants with lung nodules less than 20 mm, the test performed with an AUC value
of 0.94.

In
this 19-month trial, participants provided a sputum sample and were released from the study after a physician either confirmed the individual
was cancer-free by examination of CT imaging or confirmed the presence of lung cancer by biopsy. Flow cytometry and patient data used
in the analysis produced results that included (1) the proportion of cells with a high ratio of high TCPP fluorescence intensity over
cell size; (2) the proportion of cells with an intermediate ratio of fluorescence intensity caused by the viability dye (FVS510) over
cell size; (3) the proportion of cells that were CD206 negative but positive for one or more of the following markers: CD66b (granulocytes),
CD3 (T cells), and CD19 (B cells); and (4) patient age.

The
CyPath® Lung technology is based on scientific work originating at Los Alamos National Laboratory in collaboration with
St. Mary’s Hospital in Colorado. In the Los Alamos research study, sputum samples from lung cancer patients were differentiated
from non-cancer samples with 100% accuracy. This early research was conducted with sputum