This session explores the latest CAP/IASLC/AMP lung cancer guidelines, focusing on evidence-based testing requirements derived from the best available published literature. We will examine clinically validated methodologies and navigate specific testing strategies tailored to various resource environments. Participants will gain insights into achieving guideline-concordant results, emphasizing the laboratory director’s role in selecting appropriate LDT or IVD/CDx platforms to ensure every patient receives optimal, targeted tyrosine kinase inhibitor therapy.

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 aims to explore the co-creation of companion diagnostics (CDx) through early collaboration between development and business teams, emphasizing the critical role of early commercial input for future success. We will cover the entire lifecycle of CDx development, from biomarker selection to test commercialization, providing valuable insights and addressing various challenges and considerations.

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.

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.

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.

This session examines the evolution of precision medicine as it moves beyond oncology. We will explore how the established oncology co-development model must adapt to address more complex biomarkers and diverse patient populations. Discussions will focus on aligning diagnostic innovation with therapeutic goals, navigating broader regulatory pathways, and the essential shift toward healthcare that ensures targeted therapies reach patients across all therapeutic areas.

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.