Optimizing Oncology Diagnostic Trials: Liquid Biopsy Validation and Market Approval

Oncology diagnostics are in a renaissance of new development driven by the rise of liquid biopsy technologies that enable early, non-invasive cancer detection through blood, saliva, or urine samples. Bringing these innovative assays to market requires tailored clinical trials that validate performance against current standard-of-care methods. Unlike traditional drug trials, liquid biopsy studies face unique challenges in design, execution, and regulatory approval.

This webinar focuses on critical considerations for planning and executing clinical trials for liquid biopsy diagnostics, examining how the path to market is uniquely shaped by key decisions made during early study design and operational planning, including:

• Selecting study populations aligned with intended liquid biopsy use
• Determining sample size based on expected positivity rates
• Designing recruitment strategies for large-scale trials
• Choosing appropriate comparators and integrating investigational tests with standard care
• Setting sensitivity and specificity targets to meet regulatory and reimbursement requirements

With insights from industry leaders from Lindus Health and Harbinger Health, we’ll explore real-world experiences in planning and running successful oncology diagnostics trials—highlighting how these differ from pharmaceutical and device studies and why your strategy must adapt. Whether you’re a diagnostics sponsor, clinical operations professional, or regulatory expert, this webinar will provide practical methods to design and execute high-quality research while prioritizing participant experience.