MARLBOROUGH, Mass. — Hologic, Inc. (Nasdaq: HOLX) announced that its Genius Digital Diagnostics System has received expanded CE marking in the European Union, now enabling imaging and review of both cell and tissue specimens. Previously CE marked for cell-based analysis, including cervical cancer screening, the system can now support a wide variety of sample types, allowing European laboratories to unify digital workflows on one comprehensive platform.
The enhanced capabilities introduce whole slide imaging, a process that digitizes the entire slide for review. This advancement allows pathologists to identify precancerous lesions and cervical cancer cells during screenings, and also to review tissue biopsies for diagnostic confirmation when abnormalities are detected. The same system can now be used for breast biopsy tissue review, aiding in the diagnosis or exclusion of breast cancer. More broadly, the technology supports a range of diagnostic applications, providing greater flexibility and efficiency across pathology workflows.
Today, most laboratories rely on multiple systems to process and review different specimen types, often leading to inefficiencies, increased costs, and longer turnaround times. Hologic’s Genius Digital Diagnostics System addresses these challenges with advanced volumetric imaging technology that captures high-quality digital images of both cell and tissue specimens. The resulting images are stored, distributed, and reviewed within a single platform, streamlining operations and supporting remote review when needed.
“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 in the 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.”
“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 important step in Hologic’s innovation pipeline focused on providing accurate and efficient results to support disease screening and diagnosis.”
The Genius Digital Diagnostics System converts glass slides containing patient specimens into high-resolution digital images using volumetric imaging that captures 14 layers of the sample and compiles them into a single, two-dimensional view. The complete case is securely stored and managed through the system’s image server, where it can be accessed locally or remotely for review. The expanded CE marking also introduces new software features, including remote support, laboratory information system (LIS) readiness, and advanced review tools.
Hologic’s digital pathology solutions are CE marked in the European Union under the In Vitro Diagnostic Regulation, which is recognized in several other markets. Country-specific commercialization plans will follow. Whole slide imaging is not yet available in the United States.
