The 2018 joint molecular testing guideline from the College of American Pathologists (CAP), International Association for the Study of Lung Cancer (IASLC), and Association for Molecular Pathology (AMP) which guides patient selection for targeted tyrosine kinase inhibitor therapy in lung cancer is currently being revised. This update process examines evidence published after 2018 to determine whether existing recommendations should be strengthened or modified. Additionally, the guideline is being expanded to incorporate new recommendations covering emerging biomarkers and clinical situations that weren't addressed in the original version. During this session, attendees will receive progress updates on the revision and have the chance to discuss the changes with AMP co-chair Dr. Lindeman.

This session explores the EU COMBINE pilot’s innovative approach to coordinated regulatory review for combined clinical trials and diagnostic studies, using real-world case studies. Learn how industry sponsors streamlined submissions, engaged with regulators, and achieved faster, harmonized approvals across member states.

This presentation will provide a global regulatory perspective on companion diagnostic development, including the US, EU, and China. Topics will also include the use of clinical trial assays and local testing in clinical trials, challenges in establishing clinically meaningful cutoffs for IHC assays, and how emerging technologies and evolving regulatory policies are shaping the future of CDx development.

The shift toward AI-powered companion diagnostics is accelerating not only with computational pathology algorithms, but also with the focus on multiomics “algorithmic biomarkers" that combine data from imaging, from genomic testing, and from electronic health records. This presentation will focus on the transformative integration of AI algorithms into clinical development to optimize pre-screening, stratification, patient selection, and endpoint assessments.

Pathology based biomarkers have traditionally been developed using immunohistochemistry and manual pathologist scoring systems that are ordinal (e.g. HER2) or semi-quantitiative and cut-off based (e.g. PD-L1). Advances in computational pathology enable two additional biomarker development options: 1) AI-forward approaches capable of reproducibly measuring subtle tissue, cellular and spatial proximity features (e.g., TROP2 QCS), and 2) AI-enabled pathologist assist devices that provide adjunctive support to a pathologist (e.g., AIM-MASH). This presentation will provide an overview and real world examples of these emerging biomarker paradigms from the technical, development and regulatory perspectives.

Precision oncology is evolving from a single-analyte approach to a multimodal paradigm that integrates genomics, clinical data, and digital pathology. This presentation explores how Tempus utilizes AI-enabled platforms—including the Immune Profile Score (IPS) and Paige Predict—to extract predictive biomarkers from routine H&E imaging. We will examine the development of these AI-driven companion diagnostics (CDx) and their role in identifying therapeutic response signals that traditional molecular assays may miss. By bridging the gap between digital histopathology and clinical outcomes, we are building a more comprehensive toolkit for patient stratification and drug development.

Digital pathology has been on the precipice of an adoption inflection point for many years. Data from a recently published study from AstraZeneca and Health Advances suggests that economic justification is the single largest hurdle holding the field back.  In this talk, we will explore the development of a novel economic tool designed to help labs navigate this hurdle. In addition, we will discuss how the emergence of pharma’s interest in this field and a potential DP-based CDx approval may serve as the tipping point needed for preferential reimbursement and broader adoption.

The companion diagnostics (CDx) landscape is shifting from single-biomarker assays to complex, data-rich systems. While modern strategies prioritize advanced technologies and multi-omic innovation, ultimate success depends on the synergy between clinical development and global commercial execution. This session explores the evolving framework required to bridge the gap between drug approval and real-world patient access. We will examine the strategic pillars of successful co-development, from navigating shifting regulatory and reimbursement hurdles to overcoming the practical challenges of clinical implementation. Attendees will gain a high-level blueprint for synchronizing scientific discovery with the commercial infrastructure necessary to deliver precision medicine at scale.

Companion diagnostics (CDx) have transformed precision medicine in oncology, yet their application in non-oncology indications remains limited despite significant therapeutic potential. This presentation explores the evolving landscape of CDx in neurological, immunological, and rare disease applications. We will cover emerging non-oncology CDx applications and clinical evidence requirements; comparative FDA and EU IVDR regulatory frameworks for non-oncology and CDx; and strategies for integrating CDx into clinical trials and demonstrating clinical utility.

This session explores how precision medicine and companion diagnostics (PM & CDx) can advance personalized care in immune-mediated diseases. We will review scientific and technology enablers, including immunobiology, clinical and real-world data, AI and digital health capabilities, and maturing multiomics platforms. Drawing on established PM & CDx use cases and regulatory precedents in oncology, the session will highlight opportunities for accelerating personalized treatments for patients with immune-mediated diseases.

The convergence of AI and epigenetics is redefining what’s possible in cardiovascular medicine. Using AI, it is now possible to decode the dynamic molecular changes that reflect lifestyle impact alongside genetics to enable a new frontier in highly personalized prediction, prevention, and management of heart disease. This presentation will explore how the fusion of AI and epigenetics is delivering actionable intelligence for truly individualized cardiovascular prevention, diagnosis, and care optimization.