Hologic has received expanded CE marking in the European Union for its Genius Digital Diagnostics System, enabling the system to image and review both cell and tissue specimens. The system was previously CE marked for cell analysis, including cervical cancer screening applications.
The expanded approval enables whole slide imaging, allowing labs to use one system for multiple specimen types. The system can assist in identifying pre-cancerous lesions and cervical cancer cells during cervical cancer screenings, while also enabling pathologists to review cervical tissue biopsies. For breast health, whole slide imaging allows labs to digitize and review tissue from breast biopsies.
Most labs currently rely on multiple systems for review of different patient sample types. Using volumetric imaging technology, the Genius Digital Diagnostics System captures digital images of cell and tissue specimens to be stored, distributed, and reviewed on a single platform.
“Placing digital pathology at the center of diagnostic workflows has the potential to transform the way we approach cancer diagnosis and prevention,” said Paul van Diest, Professor, Department of Pathology at University Medical Center Utrecht. “The ability to image and review more specimen types on a single system will help pathologists think beyond traditional boundaries and bring greater accuracy and efficiency to our work.”
The system converts glass slides containing patient specimens into high-resolution digital images using volumetric imaging technology. The process simultaneously captures 14 layers of the patient specimen and converts them into a single, two-dimensional view. Cases are sent to the system’s image management server for secure storage and can be reviewed locally or remotely.
The expansion includes additional software capabilities including remote support, laboratory information system readiness, and new review tools. Hologic’s digital pathology solutions were CE marked in accordance with the In Vitro Diagnostic Regulation.
