Fig. 5. Evaluation of tissues obtained from human patients with EpiView-D4.
Brightfield cytology imaging of non-tumor human breast tissue specimens were sampled by FNA and imaged by standard benchtop microscopy (a) and brightfield imaging by EpiView (b). Left panels: LPF views by standard microscope equipped with a 10× objective lens (top) and native view on EpiView (bottom). Right panels: standard microscope image obtained by a 40× objective (top), showing the same ROI outlined with red dashed line in the 10× image, and a similar view obtained by digital zoom on the EpiView (bottom). Scale bars for LPF and HPF images are 0.2 mm and 30 µm, respectively. c, d Similar sequence of images as a and b but with a representative specimen with cytological evidence of tumor. e Results of HER2 credentialing by EpiView-D4 for 19 different patient breast tissue specimens: non-tumor, HER2-negative tumor, HER2-positive tumor (N = 7, 6, 6, respectively). Each data point represents the mean D4 fluorescence intensity (after background subtraction) of duplicate assays measured by the EpiView-D4 for an individual tissue specimen. The horizontal line represents the mean D4 signal intensity for each category. There was a statistically significant difference between groups as determined by one-way ANOVA (F (2, 16) = 9.264, p = 0.0021). Groups that are different by multiple comparison testing (Tukey post hoc test, p ≤ 0.05) are marked with different letters. HER2-positive tumors are defined as IHC 3+ or IHC 2+ with HER2 amplification by FISH. f EpiView-D4 readout vs ELISA for HER2 for all patient specimens. A strong, positive correlation between EpiView-D4 and ELISA across the 19 paired measurements is observed, which was statistically significant (Pearson r = 0.956, p < 0.0001, 95% CI: 0.886–0.983).