Hologic Genius Operator's Manual page 14

A total of 50 specimens, including at least 8 slides with counts near the clinically critical threshold
of 5000 cells, were enrolled in the study. The slides covered a range of cellularity typical of a
clinical environment. Figure 1 compares the cell counts between the Genius Cervical AI algorithm
and a manual cell count method for each specimen.
Figure 1: Deming Regression
Cell Count: Digital Imager vs. Manual
Cell counts
Manual cell count
Genius™ Digital Diagnostics System Instructions for Use English AW-22963-001 Rev. 001 3-2021 10/13