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Key takeaways
- Understand the transition from manual, semi-quantitative scoring methods to computational pathology solutions
- Identify the inherent limitations and sources of variability in traditional manual biomarker scoring
- Evaluate why computational pathology is essential for accessing future therapies where clinical benefit is tied to complex, non-visual biomarker outputs
- Understand the current regulatory landscape for companion diagnostics
- Examine a real-world case study of TROP2 (EPR20043) NSCLC RUO algorithm* and discuss emerging trends that will shape the future of oncology and pathology
Computational Pathology as the Next Generation of Companion Diagnostics
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Computational Pathology as the Next Generation of Companion Diagnostics: What Pathologists Need to Know (01:03:12)
For decades, companion diagnostics have relied on visual IHC scoring. Manual biomarker scoring is reaching its limits — future targeted therapies may respond to gradients of expression the human eye cannot reliably resolve at scale. Computational pathology may redefine companion diagnostics and the evolving role of the pathologist.
Join three Roche experts — a pathologist, an algorithm development lead, and a regulatory affairs lead — for a 60-minute panel discussion.
Hosted and moderated by Dr. Aleksandra Zuraw, DVM, PhD, DACVP — Founder, Digital Pathology Place.
Section 1: Overview
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Introduction (2:50)
Provides an overview of the webinar goals, speakers, and how computational pathology may redefine companion diagnostics.
Section 2: CDx Landscape
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CDx Landscape (7:17)
What does the companion diagnostic landscape look like today — what data are we using and how is it being scored?
Section 3: Current CDx Limitations
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Current CDx Limitations (6:46)
Where does the current companion diagnostic model begin to reach its limitations?
Section 4: CDx vs. Traditional AI tools
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CDx vs. Traditional AI tools (7:21)
How does a computational companion diagnostic differ from assistive or computer-aided AI tools?
Section 5: Future of Personalized Oncology
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Future of Personalized Oncology (4:17)
Why does personalized oncology now require higher-resolution biomarker measurement?
Section 6: What is a computational pathology CDx?
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What is a computational pathology CDx? (10:13)
What is a computational pathology–based companion diagnostic?
Section 7: Future CDx Requirements
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Future CDx Requirements (5:54)
Why is computational pathology no longer optional for certain companion diagnostics?
Section 8: Role of the Pathologist
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Role of the Pathologist (7:05)
What is the role of the pathologist in a computational companion diagnostic workflow?
Section 9: Lab Considerations
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Lab Considerations (6:32)
What must laboratories consider if computational companion diagnostics become routine?
*TROP2 RxDx received FDA Breakthrough Device Designation (BDD) in 2025 and is a product in development, not commercially available in the US. TROP2 (EPR20043) NSCLC RUO algorithm is available now in the US for Research Use Only. Not for use in diagnostic procedures.
