Leica Biosystems, a Danaher company, has announced an expansion of its strategic collaboration with AstraZeneca and Daiichi Sankyo to develop an immunohistochemistry (IHC) assay and image analysis algorithm, specifically for the TROP2 Normalised Membrane Ratio (NMR) biomarker in non-small cell lung cancer, for use as a research tool only.
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The collaboration, first announced in May 2025, is built on AstraZeneca’s proprietary computational pathology algorithm, Quantitative Continuous Scoring (QCS), using Leica Biosystems’ digital pathology solutions and IHC assay development capabilities. It establishes an end-to-end solution to assess a novel biomarker that incorporates both membrane and cytoplasmic expression. This approach advances the application of digital and computational pathology tools, including AI‑assisted algorithms, to enable the development of diagnostic approaches that have the potential to identify patients most likely to benefit from targeted therapies.
“Advancing cancer diagnostics requires more than individual innovations; it demands collaboration across science, technology, and workflow,” said Gustavo Perez-Fernandez, group executive, diagnostics, at Danaher and president of Leica Biosystems. “By working alongside AstraZeneca and Daiichi Sankyo, we are bringing together complementary expertise to help address some of the most complex challenges in biomarker research, with the aim of enabling more precise and scalable approaches that support the future of precision medicine.”
Computational pathology algorithms have the potential to enable diagnostic precision beyond traditional manual scoring methods. As pathology undergoes rapid transformation, the industry is increasingly shifting toward digital workflows enabled by whole-slide imaging (WSI), digital slide visualisation platforms, and advanced AI algorithms.
The collaboration will leverage the BOND RX research stainer, BOND-III clinical stainer, Aperio GT 450 scanner, and the Aperio HALO AP image management system from Leica Biosystems to support rapid development and global deployment of computational image analysis algorithms. The TROP2 NMR algorithm will be delivered through the Aperio AI Store, the open marketplace for AI and image analysis solutions from Leica Biosystems, enabling users to evaluate and deploy tools within a unified digital and computational pathology platform.
“This collaboration reflects the industry’s shift toward integrated best-in-class open digital ecosystems,” said Karan Arora, senior vice president of Advanced Assays, AI, and Pharma Partnerships at Leica Biosystems. “We’re proud to bring to this partnership our longstanding leadership in digital pathology, along with deep expertise in helping laboratories successfully adopt and operationalise computational workflows.”
Leica Biosystems’ initiatives reflect its commitment to advancing computational pathology innovation and establishing an integrated, end-to-end pathway for diagnostic development, from early assay feasibility through global deployment.