Hologic revealed that its Genius digital diagnostics system received expanded CE marking in the EU and is now approved to image and review both cell and tissue specimens.

The system was previously CE marked for cell analysis, notably used in cervical cancer screening, among other applications. Now that the system can image the entire slide for review of a broader range of sample types, it will allow European labs to unify digital workflows and support pathologists in their work.

“Whole slide imaging” means the same system can help identify pre-cancerous lesions and cervical cancer cells during screenings, while letting pathologists review cervical tissue biopsies to help confirm diagnosis if an abnormality is spotted.

For breast health, whole slide imaging lets labs digitize and review tissue from a breast biopsy, a crucial step when an abnormality is spotted during a mammogram to help diagnose or exclude breast cancer. This capacity isn’t limited to cervical and breast tissue—it can be used for a variety of patient sample types and diagnostic needs, Hologic said.

“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.”

Using the Genius system, glass slides with a patient specimen are converted into high-resolution digital images using volumetric imaging technology. The process simultaneously captures 14 layers of the patient specimen and converts them into a single, 2D view.

Once finished, the whole case is sent to the system’s image management server for secure storage and hands-free case management. It can be reviewed locally or remotely. The expansion also features other software capabilities like remote support, laboratory information system (LIS) readiness, and new review tools.

“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 incredible step in Hologic’s innovation pipeline focused on providing accurate and efficient results to support disease screening and diagnosis.”

Last month, the company announced it entered an agreement to be acquired by funds managed by Blackstone and TPG in a transaction valued at $79 per share, representing an enterprise value of up to $18.3 billion.