A European Medicines Agency expert group has raised concerns about notified bodies assessing companion diagnostics.
Experts from Belgium, Germany and the Netherlands said that the EMA should consider whether the current system for assessing companion diagnostics tests is still fit for purpose, according to a report released by the EMA’s Genomics, Genetics, Transcriptomics and Epigenetics subgroup.
Currently, the EMA doesn’t assess companion diagnostics and genetic testing platforms, because this is the purview of notified bodies. The report notes that in the U.S., the FDA assesses and grants approval for companion diagnostic and genetic testing platforms.
The authors suggest that a system that has a more central assessment companion diagnostics could be more beneficial and consistent.
The group noted that under the new EU IVDR that becomes effective in 2022, notified bodies will have to interact more with regulators, and notified bodies can request that the EMA and national agencies provide input on a medical device in a consultation procedure.
Such a system could lead to “variability in the assessment of diagnostic tests and hence variability in performance characteristics that may ultimately affect the benefit/risk balance of medicinal products that are used specifically based on the results of a diagnostic test,” the report said.
In the EU, when a medicinal product is administered based on a genomic diagnostic test, the requirement for industry at the time of marketing authorization is that a CE marked diagnostic test, as certified by a notified body, is available on the market, the group said.
“With the increasing complexity of genomics tests and the increasing importance of these tests in the adequate use of medicinal products (in particular in oncology, as reflected by a sharp increase in the number of oncology medicinal products, which are used specifically in patients with certain genomic characteristics), it needs to be considered whether the current system for assessment of in vitro (companion) diagnostic tests is still fit for purpose,” the report said.
For example, a guideline being drafted includes recommendations on developing predictive biomarker-based assays including companion diagnostics.
Read the report here: www.fdanews.com/12-06-19-EMA.pdf.