Fig. 3: Pilot clinical validation of the automated BCDA on FNA samples collected prior to neoadjuvant chemotherapy.

The results of BCDA were compared to cytology-based diagnosis of the FNA. a Histogram shows the 10-gene marker panel distinguished between malignant (N = 72) and benign (N = 53) FNA samples collected in the outpatient clinic using a threshold set for benign at 8.5 CM based on the prospective study (Fig. 2). b Box plot shows that cumulative methylation is significantly higher in malignant compared to benign breast LN-FNA. Mann–Whitney P values are shown. For the box plot, the whiskers are Tukey, the box is 25th and 75th percentiles, and the center bar is the median. c ROC: AUC analysis shows the discriminatory power of the 10-gene marker panel. BCDA performed with a sensitivity of 94.4%, and a specificity of 92.5%, and ROC, AUC: 0.977 (95% CI: 0.953–1.00). FNA fine needle aspiration, N number of samples.