Hologic Announces Its Genius Digital Diagnostics System Achieves Expanded CE Marking In EU, Now Approved To Image, Review Both Cell, Tissue Specimens

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.