Diaceutics organised a meeting in partnership with patient advocacy organisation Inspire2Live in January of 2020, where a group of experts came together to reflect on the impact the upcoming In Vitro Diagnostics Regulation (IVDR) could have on labs and consequently on patient care.
There was consensus among the experts at the meeting that one consequence of IVDR is the imposition of severe limitations on the use of laboratory developed tests (LDTs), in favour of the use of corresponding commercially available tests.
This new more stringent approach to LDT use may initially translate in unavailability of diagnostic tests that are compliant with the regulation because there is a general lack of understanding of specific elements of the regulation and guidance is still lacking. Additionally, the increased need for involvement of a notified body (NB) in the process of In Vitro Diagnostic (IVD) certification is in stark contrast to current and near future NB capacity1. Moreover, the current and near future capacity of Notified Bodies for certification of IVD falls far short of the increased certification workload imposed by IVDR on diagnostics manufacturers.
Both, the lack of clarity of exemptions for LDT use and the limited capacity in the infrastructure toward compliance, will impact the work of a large number of laboratories across Europe and compromise the deployment of tests for a number of biomarkers associated with precision therapy, particularly in oncology. This could potentially negatively impact patient care, as patients would be unable to access therapy options relevant to them which are guided by IVDs.
The pharmaceutical industry should be paying close attention to avoid:
- Extended time to peak adoption due to reduced testing capacity
- Reduced choice of therapy
- Patients lost to follow-up due to reduced testing capacity
- Ultimately, having patients miss out on therapy options which optimise their outcomes.
Collaboration is the key to IVDR preparedness by:
- Ensuring that there is IVDR awareness across EU labs
- Enhancing labs’ ability to provide their local Competent Authorities with evidence of QUALITY
- Labs taking proactive steps to be IVDR compliant
- Labs being part of an EU wide community that collaborates to support the national efforts.
For more information on IVDR collaboration opportunities, register for the latest Diaceutics IVDR Report here
- Notified bodies - Capacity vs Workload - MedTech Europe. Accessed February 11, 2021