Approach IVDR, Global Trials & CDx with Confidence: How the Right Diagnostics Partner Can Make It Possible
Time: 10:00 am
day: Conference Day Two - AM
Details:
- Learn about Foundation Medicine’s regulatory approach, and how existing platform validation data can accelerate timelines for CDx approval
- Gain insights and expectations on the study start-up process across different countries, such as China and Europe, with a focus on our experience through notification and authorization pathways under IVDR
- Look at what’s ahead, with new biomarkers like HRDsig and ctDNA tumor fraction, as well as possibilities for CDx milestones across RNA, heme malignancies, and real-world data
