Hologic announced that its Genius Digital Diagnostics System has received an expanded CE marking in the European Union, extending regulatory approval from cell‑only to include tissue specimens. The new approval allows the system to image and review both cell and tissue samples, enabling whole‑slide imaging across a broader range of pathology workflows.
The expanded capability means that laboratories can now use the Genius platform for cervical cancer screening, breast biopsies, and other diagnostic procedures that require tissue analysis. By consolidating cell and tissue imaging into a single system, Hologic aims to reduce fragmentation in digital pathology workflows, lower operational costs, and shorten turnaround times for pathologists.
Hologic’s broader strategy is reflected in its recent financial performance. Revenue grew from $987.9 million in fiscal Q4 2024 to $1.0495 billion in fiscal Q4 2025, while diagnostics revenue increased 6.5 % in Q4 2024 and 5.1 % in Q1 2025, driven largely by molecular diagnostics. The company’s diagnostics segment, which includes digital pathology, has been a key growth engine, and the CE‑mark expansion positions it to capture additional market share in Europe.
In the competitive digital pathology landscape, Hologic now competes more directly with firms that offer integrated whole‑slide imaging solutions. The expansion addresses a market trend toward end‑to‑end digital workflows and positions Hologic to offer a more comprehensive platform, potentially strengthening its foothold against rivals such as Philips, Leica, and Roche. The move also aligns with the company’s ongoing portfolio expansion and its planned transition to private ownership under Blackstone and TPG, expected to close in the first half of 2026.
Management highlighted the regulatory milestone as a critical step in expanding the company’s diagnostic portfolio and enhancing its competitive position in digital pathology. While the announcement does not include a specific financial projection for the new capability, the expansion is expected to drive incremental sales in European laboratories and support Hologic’s broader strategy of delivering integrated, high‑value diagnostic solutions.
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