MARLBOROUGH, Mass.--(BUSINESS WIRE)-- Hologic, Inc. (Nasdaq: HOLX) announced today that its Genius™ Digital Diagnostics System achieved expanded CE marking in the European Union and is now approved to image and review both cell and tissue specimens. Previously, the system was CE marked specifically for cell analysis, notably used in cervical cancer screening, among other applications. With the ability to image the entire slide for review of a broader range of patient sample types, the Genius Digital Diagnostics System will allow European labs to unify digital workflows with one comprehensive solution and support pathologists in their work diagnosing a variety of cancers and other diseases.

The ability to image the entire slide is known as “whole slide imaging.” This means that, for example, the same 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 to help confirm diagnosis if an abnormality is detected. Similarly, for breast health, whole slide imaging allows labs to digitize and review tissue from a breast biopsy – a crucial step when an abnormality is detected during a mammogram to help diagnose or exclude breast cancer. Importantly, this capability is not limited to cervical and breast tissue; it can be leveraged for a wide variety of patient sample types and diagnostic needs, supporting more comprehensive and flexible pathology workflows.

Today, most labs rely on multiple systems for review of different patient sample types. This separation can create inefficiencies for the lab, which can increase operational costs, extend turnaround times and create additional work for lab staff. Using advanced volumetric imaging technology, Hologic’s Genius Digital Diagnostics System offers the ability to efficiently capture high quality digital images of cell and tissue specimens to then be stored, distributed and reviewed all 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, 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, 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.”

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