Roche retained top position in the 2025 CNS Summit Digital Innovation Index, marking its second consecutive year at number one and fourth 1st-place finish. The company-maintained leadership across all subcategories, ranking 1st in commercial, 3rd in clinical, and 9th in research.

Roche strengthened its digital pathology and diagnostics portfolio with additional FDA 510(k) clearance for a high- volume whole-slide imaging system that enhances laboratory throughput across surgical pathology and in vitro diagnostic workflows.

The platform is therapeutic area agnostic, supporting digitization of hematoxylin and eosin (H&E) and immunohistochemistry (IHC) slides across a wide range of disease areas. Roche also received FDA Breakthrough Device Designation for an AI- enabled computational pathology companion diagnostic in non-small cell lung cancer (NSCLC), paving the way for regulated algorithmic scoring in precision oncology.

Roche and IBM advanced their collaboration in continuous glucose monitoring (CGM), progressing from record keeping to predictive decision support.

The Accu- Chek SmartGuide CGM launched in 13 countries last year, demonstrating reductions in severe hypo- and hyperglycemic episodes. The system has now received CE marking for integration with the mySugr App, broadening access to AI-based predictive monitoring and supporting planned expansion to an additional 30 countries.

Beyond pathology, Roche expanded its AI footprint through partnerships with Qure.ai, extending imaging capacity in resource-constrained settings, and Telstra Health, piloting digital care navigation tools that link referrals, appointments, and test results. Together, these initiatives demonstrate how AI can be embedded into clinical workflows rather than operating as isolated pilots.

In genomic sequencing, Roche advanced its proprietary Sequencing by Expansion (SBX) technology, which is an ultra-rapid, high-throughput platform for decoding complex diseases in oncology, immunology, and neurology. In collaboration with Broad Clinical Labs, SBX was applied to whole-genome sequencing in neonatal intensive care, aiming to establish genome sequencing as a routine component of clinical decision-making.

Roche also announced the development of a foundation AI model with Harvard researchers to predict and explain immunotherapy response across 33 cancer types. In diagnostics, the company launched the cobas Respiratory Flex Test, the first to use its proprietary Temperature-Activated Generation of Signal (TAGS) technology, which combines multiplex PCR with temperature-based signal generation for faster, more precise detection of respiratory pathogens.

In 2025, Roche reaffirmed its leadership in regulated, scalable AI and digital health innovation, leveraging connected diagnostics, software, and analytics to shape more personalized and sustainable models of care.