- In April 2025, F. Hoffmann-La Roche Ltd (Switzerland) announced that its VENTANA TROP2 (EPR20043) RxDx Device received FDA Breakthrough Device Designation. This is the first Breakthrough Device Designation for a computational pathology companion diagnostic (CDx) device, leveraging AI-based image analysis for non-small cell lung cancer (NSCLC) to enable more precise diagnosis
- In April 2025, Agilent Technologies Inc. (U.S.) received European IVDR certification for its PD-L1 IHC 22C3 pharmDx companion diagnostic assay for use in gastric or gastroesophageal junction (GEJ) adenocarcinoma. This expands its utility in identifying patients eligible for KEYTRUDA therapy
- In April 2025, Leica Biosystems and Bio-Techne expanded their partnership to offer innovative spatial multiomics solutions for automated spatial multiomics on the BOND RX Research Staining Instrument, further advancing the capabilities of spatial biology research
- In March 2025, Leica Biosystems and CellCarta partnered to accelerate companion diagnostics development in China. This collaboration aims to provide pharmaceutical and biotechnology companies with a comprehensive range of biomarker services in China for China
- In January 2025, Leica Biosystems launched the HistoCore CHROMAX Workstation, advancing its coverslipping and staining portfolio. This new workstation automates reagent management, enhancing efficiency in anatomical pathology workflows
- In January 2025, Philips (Netherlands) and Ibex Medical Analytics (Ibex) expanded their partnership to further accelerate the adoption of AI-enabled digital pathology workflows for better patient care. This aims to improve diagnostic accuracy and efficiency in prostate, breast, and gastric cancer diagnostics
