Hologic expands Genius digital pathology system with CE marking
Hologic has announced expanded CE marking for its Genius Digital Diagnostics System in the European Union, enabling the platform to image and review both cell and tissue specimens. The approval represents a significant expansion from the system’s previous CE marking, which was limited to cell analysis applications such as cervical cancer screening.
Unified workflow for multiple specimen types
The enhanced capabilities introduce whole slide imaging functionality, allowing pathologists to use a single system for diverse diagnostic applications. For cervical cancer screening, the platform can now identify pre-cancerous lesions and cancer cells during initial screening whilst also enabling review of cervical tissue biopsies to confirm diagnosis. In breast health applications, the system supports tissue review from breast biopsies following mammogram abnormalities.
“Placing digital pathology at the centre of diagnostic workflows has the potential to transform the way we approach cancer diagnosis and prevention,” said Paul van Diest, Professor in the Department of Pathology at University Medical Centre 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.”
Volumetric imaging technology
The Genius Digital Diagnostics System employs volumetric imaging technology that simultaneously captures 14 layers of patient specimens, converting them into a single two-dimensional view. Glass slides containing specimens are rapidly converted into high-resolution digital images, which are then transferred to the system’s image management server for secure storage and case management. Images can be reviewed locally or remotely.
The expansion includes additional software capabilities such as remote support, laboratory information system readiness, and new review tools. These features address operational challenges that laboratories face when managing multiple systems for different specimen types, which can increase costs, extend turnaround times, and create additional workload for laboratory staff.
Regulatory status and availability
The digital pathology solutions received CE marking in accordance with the In Vitro Diagnostic Regulation, which is recognised by multiple countries globally. Commercialisation schedules will be announced on a per-country basis. Whole slide imaging is currently not available in the United States.
“Access to innovative technology in the laboratory can be a foundation for better patient care,” said Jennifer Schneiders, Ph.D., President of Diagnostic Solutions at Hologic. “Expanding our CE marking with digital pathology will help bring advanced technology to more laboratories across Europe and signals another incredible step in Hologic’s innovation pipeline focused on providing accurate and efficient results to support disease screening and diagnosis.”
- For more information, visit: https://www.hologic.com/
