At Amplion we have a commercial interest in access to high quality clinical information that can inform and contribute to our flagship product, BiomarkerBase. However, we are truly passionate about contributing to higher quality, more personalized, medical advancements that improve the overall health of our communities. We want to contribute to delivering on the promise of personalized medicine.
When we see things in research and in the market that threaten that promise we feel an obligation to comment. Recently, a column written by Ronald Boumans and Stewart Eisenhart of Emergo on the state of the EUDAMED project in the EU caught our attention.
As a refresher, EUDAMED is a database intended to cover medical devices in Europe. The EUDAMED database is one piece from the 2011 Medical Device Regulation Directives from the European Commission. The goal of the creation of EUDAMED would be to increase the transparency of medical devices in Europe. This includes IVD tests.
We've written a lot about the importance of test to quality medical care and personalized medicine, and have released a report that covers test trends in detail.
Unfortunately, the column from Boumans and Eisenhart confirmed that access to EUDAMED, currently limited to EU competent authorities for member countries, is at least 3 1/2 years out. While we don't doubt that EUDAMED will be public at some point, we are concerned that there is not a higher sense of urgency to make it available sooner than 10 years after first announced.
This mirrors some concerns we've had in the US about the FDA's uncertain guidance on Laboratory Developed Tests and a long history of regulation discussions. The issue here is very similar. Both CE marked tests, that will be available in EUDAMED, and LDTs are key to personalized medicine. Ensuring access to information about these tests to everyone in the medical value chain is critical to the success of personalized medicine. Drug and diagnostic developers need to understand the current landscape of critical pieces like companion diagnostics. Physicians need detailed understanding of a test's goals and quality.
The FDA has ambiguously retained “enforcement discretion for premarket review and quality system requirements” for traditional LDTs and those used in rare disease. A central registry of LDTs has been discussed for some time now, but delivery and format has yet to be specified.
In both cases the lack of public access to databases of these tests will delay real progress on personalized medicine. We emplore the European commissioners and the FDA to expedite the work on making EUDAMED public and creating an LDT registry, respectively. Access to an incomplete EUDAMED and LDT registry is better than no access at all.