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Hologic Obtains CE Mark for AI-Based Cervical Cancer Screening Platform

NEW YORK ─ Hologic on Tuesday announced it has obtained the CE mark for its Genius Digital Diagnostics cytology platform for cervical cancer screening, enabling its use in Europe and other regions that accept the designation.

Genius Digital Diagnostics consists of a digital imager for image acquisition, an artificial intelligence algorithm for analyzing images, an image management server for storing images, and a review station for case review. The system is scalable and can fit present and future needs of laboratories, while helping cytotechnologists and pathologists identify pre-cancerous lesions and cancer cells in women, Hologic said.

The Marlborough, Massachusetts-based firm added that its platform rapidly analyzes all cells on a Hologic ThinPrep Pap test slide, narrowing tens of thousands of cells to a gallery view of the most diagnostically relevant images. Clinicians can use this information to guide earlier detection and better treatment decisions for patients.

The cytology platform also enables seamless collaboration among laboratories within a network and remote review so that each patient can benefit from the collective knowledge of geographically dispersed experts when needed, the firm said.

For cervical cancer screening, Hologic already markets its ThinPrep Pap Test, a liquid-based cytology assay, and its Aptima HPV Assay, the first US Food and Drug Administration-approved mRNA-based HPV test.