NGS IVD Challenges Under IVDR | Scientific Validity & Clinical Performance Explained
Автор: MDx CRO
Загружено: 2026-02-12
Просмотров: 16
Описание:
What are the main challenges when bringing an NGS IVD to market under IVDR?
In this interview, Marketa explains why demonstrating scientific validity and clinical performance remains one of the biggest hurdles for Next-Generation Sequencing (NGS) in vitro diagnostics.
When NGS assays analyse hundreds or even thousands of biomarkers simultaneously, the volume and complexity of data make it significantly more challenging to generate robust clinical evidence. Proving that each marker is clinically relevant, and supported by strong scientific justification, is critical for IVDR compliance.
This discussion explores:
• The regulatory expectations for NGS IVDs under IVDR
• The complexity of large-scale genomic data
• The challenges in building strong clinical evidence
• Why scientific validity is central to regulatory approval
Watch the full interview to gain insight into the regulatory landscape for NGS IVDs and the evidence strategy required for successful market access.
Повторяем попытку...
Доступные форматы для скачивания:
Скачать видео
-
Информация по загрузке:
