A Four-Year Journey Utilising In-House Devices for Clinical Trials
- Implementation of IVDR in 2022 strictly limited the use of lab developed tests (LDTs) in clinical trials
- Discovery Life Sciences’ Kassel Germany facility is a qualified Health Institution and has 4 years of experience utilizing LDTs to support patient management in EU clinical trials under IVDR
- Discovery’s approach to developing clinical trial assays (CTA) under this system will be discussed along with illustrative case studies