Hologic 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.
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.
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 recognized by other countries around the world. Commercialization per country will be announced. Whole slide imaging is currently not available in the United States.
Read Hologic's announcement here
