In Vitro Diagnostics are crucial in the delivery of optimal patient care. Treatment decisions are made for every patient at different stages of the treatment pathway based on the results from these tests.
In Europe, the upcoming In Vitro Diagnostics Regulation (IVDR) presents a new regulatory approach to the development, validation, and assessment of in vitro diagnostics. This new approach will be considerably more stringent than the previous In Vitro Devices Directive (IVDD), particularly with regards to the use of laboratory developed tests (LDTs), also referred to as in-house testing.
There are concerns among stakeholders regarding the potential negative impact of the IVDR on patient care, because LDT use varies greatly across Europe. In some countries, LDT use is up to 60%1. Furthermore, the size of the LDT problem is just as concerning when looking at it by methodology use2 (e.g. next generation sequencing, polymerase chain reaction, fluorescence in-situ hybridization) or by biomarker3 (e.g. PD-L1, BRAF, ALK, EGFR).
These concerns are exacerbated by the fact that the infrastructure required to support transition toward compliance is lacking. Additionally, there are many uncertainties regarding some of the aspects which guide the in-house exemption rules in Article 5 and the guiding documents for its interpretation are lacking.
Combined, these and other issues, addressed in the report, have the potential to translate into a lack of availability of tests which comply with the regulation. If unprepared, laboratories might not be able to perform crucial tests guiding treatment decisions which will negatively impact patient care. It is important that laboratories make an inventory of their practices to understand how to prepare operations for IVDR compliance.
It is also important for the pharmaceutical industry to understand these limitations to the delivery of their innovations and how to play an active role in supporting a smooth transition toward IVDR compliance in order to facilitate access to relevant targeted treatment options and undisrupted patient care.
Diaceutics’ DXRX platform is facilitating collaborations which address an informed role both for laboratories as well as for the pharmaceutical industry, to ensure patient care is not negatively impacted. Furthermore, the upcoming IVDR Report is an example of the importance of network collaboration, as the team of experts who came together to collaborate on it is already proving pragmatic solutions in several sections of the report.
For more information on IVDR collaboration opportunities register for the latest Diaceutics IVDR Report here
References
- Vermeersch P, Van Aelst T, Dequeker EMC. The new IVD Regulation 2017/746: a case study at a large university hospital laboratory in Belgium demonstrates the need for clarification on the degrees of freedom laboratories have to use lab-developed tests to improve patient care. Clin Chem Lab Med. 2020 Jul 21:/j/cclm.ahead-of-print/cclm-2020-0804/cclm-2020-0804.xml. doi: 10.1515/cclm-2020-0804. Epub ahead of print. PMID: 32692695.
- Laboratories self-report through DXRX platform
- Laboratories self-report through DXRX platform
