Hologic has announced 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 laboratories to unify digital workflows with one comprehensive solution and support pathologists in their work diagnosing a variety of cancers and other diseases.
Using whole slide imaging means that 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 laboratories to digitise 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 laboratories rely on multiple systems for review of different patient sample types. This separation can create inefficiencies, which can increase operational costs, extend turnaround times and create additional work for laboratory 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 centre 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 PhD, 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.”
With the Genius Digital Diagnostics System, glass slides containing a patient specimen are quickly converted into high-resolution digital images using volumetric imaging technology. This process simultaneously captures 14 layers of the patient specimen and converts them into a single, two-dimensional view. Once complete, the entire case is sent to the system’s image management server for secure storage and hands-free case management. It can then be reviewed locally or remotely, helping experts make an interpretation or diagnosis efficiently. This process is now applicable to cell and tissue specimens. The expansion also comes with additional software capabilities such as remote support, laboratory information system (LIS) readiness, new review tools and more.
Hologic’s digital pathology solutions were CE marked in the European Union in accordance with the In Vitro Diagnostic Regulation, which is also recognised by other countries around the world. Commercialisation per country will be announced. Whole slide imaging is currently not available in the United States.