Hologic’s HOLX Genius Digital Diagnostics System has achieved expanded CE marking in the European Union. The development signals a promising step in the company’s innovation pipeline focused on providing accurate and efficient results to support disease screening and diagnosis. The Genius Digital Diagnostics System was previously CE marked specifically for cell analysis — notably used in cervical cancer screening among other applications — and is now approved to image and review both cell and tissue specimens and is now approved to image and review both 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.
Labs today largely labs rely on multiple systems for review of different patient sample types. This separation can create inefficiencies for the lab, which can increase operational costs, extend turnaround times and create additional work for lab staff. Using advanced volumetric imaging technology, the 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 center of diagnostic workflows has the potential to alter the existing approaches to cancer diagnosis and prevention. The ability to image and review more specimen types on a single system can help pathologists go beyond traditional boundaries and bring greater accuracy and efficiency to work. Expanding the CE marking with digital pathology supports broader access of Hologic’s advanced technology across European labs.
In the fourth quarter of fiscal 2025, Hologic’s cytology and perinatal businesses increased 5.7% year over year, aiding the Diagnostics growth. The rollout of the Genius digital diagnostics system to more labs around the world has been positively impacting revenues.
Updates From Hologic’s Diagnostics Peers
Thermo Fisher Scientific TMO secured FDA’s 510(k) clearance of the EXENT Analyser and Immunoglobulin Isotypes (GAM) Assay, a first-of-its-kind automated platform for clinical laboratories. The EXENT System combines enhanced sensitivity and automation to provide accurate results, helping clinicians make a fast diagnosis for patients with multiple myeloma and related disorders. Thermo Fisher also recently announced a definitive agreement to acquire Clario Holdings, Inc., a provider of endpoint data solutions for clinical trials.
QIAGEN N.V. QGEN announced the debut of QIAsymphony Connect, the next generation of automated nucleic acid purification platform, at the 2025 AMP (Association for Molecular Pathology) annual meeting from November 11-15 in Boston. QIAsymphony Connect introduces a range of significant improvements that enhance performance, speed and connectivity across various diagnostic and research workflows. Additionally, QIAGEN has entered into a definitive agreement to fully acquire Parse Biosciences, a leading provider of scalable, instrument-free solutions for single-cell research.
HOLX Stock Performance, Valuation and Estimates
In the past six months, Hologic’s shares have risen 34.8% compared with the industry’s 13.9% growth.
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Hologic is trading at a forward five-year price-to-sales (P/S) of 3.86X, lower than the industry average of 4.40X.
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See how analysts are projecting Hologic’s fiscal 2026 and 2027 earnings.
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HOLX stock currently carries a Zacks Rank #3 (Hold).You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.
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