As liquid biopsies become more commonplace, gaining wider FDA acceptance and even becoming standard of care in some instances, the technology is giving rise to important new questions. In this webinar, we will explore the technique’s growing importance in early cancer detection and address common questions about its use. Topics will include:
- Developing your test: clinical, analytical, and performance validation considerations
- Approaching single indication vs. multi-cancer screen indications
- Lab-developed tests vs. premarket approval: advantages and disadvantages
- The regulatory landscape for in vitro diagnostics
- Strategies for operationalizing large-scale clinical validation studies
Speakers:
Charlie Chrisawn, Executive Director, Program Strategy, In Vitro Diagnostics
Michael Edwards, Senior Director, Regulatory Affairs, MedTech