EMA Subgroup Questions Use of NBs to Assess Companion Diagnostics

Regulatory NewsRegulatory News | 27 November 2019 |  By 

While discussing the use of genomics data in regulatory processes, a subgroup of the European Medicines Agency (EMA) also called for a reconsideration of the current system of using notified bodies (NBs) to assess companion diagnostic tests, according to a 69-page report released Wednesday.

The report on genomics data, including epigenetics and transcriptomics data, features recommendations from experts in Netherlands, Germany and Belgium on “how to optimise the future use of genomics (big) data in regulatory processes.”

On the issue of NBs and IVDs, they explain: “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.”

Although they note that the use of the new IVD regulation will begin in 2022, the subgroup does not discuss the potential for a lack of NBs, but they do explain how NBs will need to interact more with competent authorities under the new regulation.

For example, before issuing an EU technical documentation assessment certificate for a companion diagnostic, the NBs will consult the competent authority on the suitability of the device in relation to the medicinal product, Didier Meulendijks, Dieter Deforce, Hans Ovelgönne, Renate König and subgroup lead Marjon Pasmooij write.

“However, the responsibility for assessment will still lie with a variety of notified bodies, potentially leading to variability in the assessment of diagnostics 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. A system in which central assessment of in vitro (companion) diagnostic tests is performed could potentially be beneficial in this respect,” they write.

The report also discusses the importance of guidance, noting how currently a guideline is being drafted by the EMA’s Pharmacogenomics Working Party on the recommendations on developing predictive biomarker-based assays, including companion diagnostics.

But they also took issue with the guidance that exists on data standardization for genomics data. “To optimise data sharing it would be beneficial to agree on standardised data formats of genomics data and clinical outcome data to allow better linkage and ability to share data,” they write.

“[D]ata sources usually couple genomics data to information on disease, but do not couple genomics data to treatment outcomes. The latter would be useful in the regulatory context,” they write. And they take issue with the lack of a framework to address the security and privacy issues associated with sharing genomics and clinical outcome data.

The value of genomics data from a regulatory perspective, they explain, lies mainly with the linkage of genomics data with “sources of phenotypic and/or clinical outcome data.”

The report also calls for EMA to initiate a pilot study to link genomics data to clinical outcome data from different efficacy and safety studies if investigators or marketing authorization holders are willing to cooperate. “This could be relevant for both oncology and rare diseases,” they write.

Other reports were also released today from subgroups on Observational data (Real World Data), Spontaneous Adverse Drug Reactions, Social Media and M-Health Data, Clinical Trial and Imaging, Bioanalytical Omics and Data Analytics.

Genomics Genetics, Transcriptomics and Epigenetics Subgroup report


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