Overcoming regulatory obstacles in omics-driven IVD approval: Panel discussion

May 13, 2025, at 15:00 BST / 16:00 CEST / 10:00 EDT / 9:00 CDT / 7:00 PDT

The development, approval, and delivery of advanced molecular in vitro diagnostics (IVD) is a complex and lengthy process, often hindered by numerous barriers. These challenges range from access to high-quality orthogonal datasets and properly consented specimens with associated longitudinal health records, to navigating a vast array of tools, solutions, and platforms for biomarker discovery, result generation, regulatory submission, and regulatory approval acceleration using component registered and cleared devices.

Our upcoming panel discussion will explore how leading scientists are tackling key barriers in molecular in vitro diagnostic research and development.

Join the roundtable to hear answers to your questions, including:

• What are the key challenges, solutions, and considerations when building fit-for-purpose analytics pipelines?
• What does it take to analytically and clinically validate omics-based molecular diagnostics?
• How can you reduce time to deployment, enable scalability, and improve the quality of regulatory submissions?
• Why is end-user software experience critical to facilitating IVD delivery?
• How are omics-driven IVDs evolving?

Key learning objectives

• Navigating development challenge: Understand the key barriers in developing advanced ‘omics-based diagnostics, from ideation and hypothesis testing to market access, verification, validation, and regulatory approval.
• Optimizing data access and quality: Learn how to overcome challenges in acquiring high-quality datasets, consented specimens, and longitudinal health records to support robust diagnostic development.
• Harnessing advanced analytics and technologies: Explore cutting-edge data analytics, insights generation solutions, and emerging technologies that can address development and regulatory hurdles.
• Accelerating market readiness: Discover how integrated informatics and regulated software solutions can streamline regulatory approval and speed up the delivery of high-quality molecular diagnostics.

Certificate of attendance

All webinar participants can request a certificate of attendance, including a learning outcomes summary, for continuing education purposes.

If you view the on-demand webinar, you can request a certificate of attendance by emailing editor@selectscience.net.