This webinar was recorded on Wednesday, 6th November 2024.

Join us for an in-depth exploration of the emerging applications and platforms in liquid biopsy. This session will highlight the most recent advancements in early cancer detection and targeted therapies, while also addressing critical challenges in patient access and reimbursement. Featuring thought leaders from across the industry, this webinar will provide valuable insights into the innovations shaping the future of liquid biopsy and its clinical impact.

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Speakers:

• Rehan Verjee, Chief Executive Officer at Precede Biosciences‍
• Dawn Mattoon, Chief Executive Officer at Mercy BioAnalytics, Inc.
• Peter Bach, Chief Medical Officer at DELFI Diagnostics
• Sarah Clancey Overton, Director of RCM at Velsera
• Mark Sausen, Executive Director, Head of Technology Innovation, PGDx, Labcorp

Moderators:

• Andrew Aijian, Ph.D., Partner at DeciBio Consulting
• Rishi Kayathi, Product Manager at DeciBio Consulting
• Juilee Malavade, Ph.D., Life Science Expert at DeciBio Consulting

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Key Takeaways:

Emerging Applications:

• Liquid biopsy use cases are expanding, notably in minimal residual disease (MRD) detection and recurrence monitoring. The distinction was emphasized:‍
  • MRD tests aim to detect residual cancer cells immediately following treatment to identify relapse risk early.‍
  • Recurrence Monitoring focuses on detecting the return of cancer in patients who have been declared disease-free, serving as a longer-term surveillance tool.

• The webinar also highlighted the growing interest in multi-cancer early detection (MCED) tests.

Technological Innovations:

• Advances in next-generation sequencing (NGS) platforms and novel biomarkers like methylation patterns and fragmentomics are enhancing liquid biopsy sensitivity and specificity.
• Emerging methods, particularly for ctDNA detection, are driving innovations in MRD and recurrence monitoring, offering clinicians actionable insights.
• Automation and integration with digital pathology are streamlining workflows, increasing throughput, and reducing time to results in clinical settings.

Commercialization Challenges:

• Many liquid biopsy assays are still in the early stages of commercialization. High costs, complex biomarker development, and the need for strong clinical validation data are barriers to broader adoption.
• Specific applications (e.g., MRD, recurrence monitoring, and early detection) face unique commercialization hurdles, with differing stakeholder expectations and market dynamics.

Regulatory and Reimbursement Landscape:

• The regulatory pathway for single-cancer liquid biopsy tests for therapy selection is increasingly defined, with the FDA providing clearer guidance. However, MRD, recurrence monitoring, and multi-cancer early detection tests face a less established regulatory process, requiring more robust data on sensitivity, specificity, and clinical utility.
• Reimbursement continues to be a significant challenge, particularly for tests outside the U.S., where regulatory requirements and payer expectations vary widely.

Collaborative Ecosystem:

• Collaboration among biopharma, diagnostics companies, and academic institutions was highlighted as a key driver of innovation. These partnerships are seen as crucial for advancing assay development and achieving clinical adoption.

Future Outlook:

• The panelists expressed optimism about the future of liquid biopsy, anticipating growth in MRD and recurrence monitoring applications. While MCED tests show promise, the focus remains on areas with immediate clinical utility and clearer adoption pathways.
• Continued advancements in biomarker discovery and NGS technologies, coupled with strategic partnerships, are expected to drive broader clinical integration and adoption.

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View the webinar recording and slides below:

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