Hologic announces FDA-cleared digital cytology system – Genius Digital Diagnostics System

Feb. 5, 2024
Latest diagnostic system for cervical cancer screening.

Hologic, Inc. announced that its new Genius Digital Diagnostics System with the Genius Cervical AI algorithm has received clearance from the U.S. Food and Drug Administration (FDA).

Screenings for cervical cancer include a Pap test, where a sample is generally collected at an OB-GYN office, and the cervical cells are sent to a lab where they are transferred to a glass slide. To date, this glass slide has been reviewed under a microscope. With the Genius Digital Diagnostics System, the glass slides are digitally imaged and an artificial intelligence algorithm is applied to pinpoint the cells that cytologists and pathologists should review.

The new process and technology demonstrated an overall improvement in sensitivity without a corresponding decrease in specificity.

The system allows cytologists and pathologists to securely review cases remotely, so patients can benefit from the collective knowledge of geographically dispersed experts.

Hologic release