Critical Implications of IVDR for Innovation in Diagnostics: Input From the BioMed Alliance Diagnostics Task Force

Dombrink, Isabel; Lubbers, Bart R; Simulescu, Loredana; Doeswijk, Robin; Tkachenko, Olga; Dequeker, Elisabeth; Fraser, Alan G.; Dongen, Jacques J.M. van; Cobbaert, Christa; Brüggemann, Monika; Macintyre, Elizabeth

doi:10.1097/hs9.0000000000000724

Cited by 8 publications

(8 citation statements)

References 7 publications

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“…The diagnostic community should be aware of the significant differences in unit costs, due indirectly or directly to outsourcing and the added costs of IP in the manufacturing sector. These considerations will also apply to the cost of CE‐marked NGS assays, particularly after application of IVD Regulation 2017/746 12 . It is premature to estimate the economic impact of this European legislation, because it will impact many aspects of diagnostic practice, with probable increases in unit costs, potentially partially offset by increasing centralization.…”

Section: Discussionmentioning

confidence: 99%

Targeted High-throughput Sequencing for Hematological Malignancies: A GBMHM Survey of Practice and Cost Evaluation in France

Darlington,

Sujobert,

Kosmider

et al. 2023

HemaSphere

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The objective of this study was to assess the clinical impact and financial costs of next-generation sequencing (NGS) in 5 categories of pediatric and adult hematological cancers. NGS prescriptions were prospectively collected from 26 laboratories, with varied technical and reporting practice (all or only significant targets). Impact was defined by the identification of (1) an actionable mutation, (2) a mutation with prognostic and/or theranostic value, and/or (3) a mutation allowing nosological refinement, reported by local investigators. A microcosting study was undertaken in 4 laboratories, identifying the types and volumes of resources required for each procedural step. Individual index prescriptions for 3961 patients were available for impact analysis on the management of myeloid disorders (two thirds) and, mainly mature B, lymphoid disorders (one third). NGS results were considered to impact the management for 73.4% of prescriptions: useful for evaluation of prognostic risk in 34.9% and necessary for treatment adaptation (actionable) in 19.6%, but having no immediate individual therapeutic impact in 18.9%. The average overall cost per sample was 191 € for the restricted mature lymphoid amplicon panel. Capture panel costs varied from 369 € to 513 €. Unit costs varied from 0.5 € to 5.7 € per kb sequenced, from 3.6 € to 11.3 € per target gene/hot-spot sequenced and from 4.3 € to 73.8 € per target gene/hot-spot reported. Comparable costs for the Amplicon panels were 5–8 € per kb and 10.5–14.7 € per target gene/hot-spot sequenced and reported, demonstrating comparable costs with greater informativity/flexibility for capture strategies. Sustainable funding of precision medicine requires a transparent discussion of its impact on care pathways and its financial aspects.

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Section: Discussionmentioning

confidence: 99%

Targeted High-throughput Sequencing for Hematological Malignancies: A GBMHM Survey of Practice and Cost Evaluation in France

Darlington,

Sujobert,

Kosmider

et al. 2023

HemaSphere

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“…Consequently, the Coordinated Commission of Clinical Microbiology of the Swiss Society of Microbiology considers it very important to make all efforts to lobby against this complexification of the regulations, which will clearly fail to meet its objectives. The authors clearly state that the ISO 15189 accreditation (or equivalent accreditation) norm and its routine application, as well as the Swissmedic certification, provide a legal framework that is strict enough to push all laboratories towards high-quality practices, as already exemplified by other medical laboratory disciplines [ 21 , 22 ].…”

Section: How To Face the Problems Raised By The Regulationmentioning

confidence: 99%

IVDR: Analysis of the Social, Economic, and Practical Consequences of the Application of an Ordinance of the In Vitro Diagnostic Ordinance in Switzerland

Coste,

Egli,

Schrenzel

et al. 2023

Diagnostics

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IVDR regulation represents a major challenge for diagnostic microbiology laboratories. IVDR complicates a broad range of aspects and poses a risk given the high diversity of pathogens (including rare but highly virulent microbes) and the large variety of samples submitted for analysis. The regular emergence of new pathogens (including Echovirus E-11, Adenovirus 41, Monkeypox virus, Alongshan virus, and Enterovirus D68, as recent examples in Europe in the post SARS-CoV-2 era) is another factor that makes IVDR regulation risky, because its detrimental effect on production of in-house tests will negatively impact knowledge and expertise in the development of new diagnostic tests. Moreover, such regulations negatively impact the availability of diagnostic tests, especially for neglected pathogens, and has a detrimental effect on the overall costs of the tests. The increased regulatory burden of IVDR may thereby pose an important risk for public health. Taken together, it will have a negative impact on the financial balance of diagnostic microbiology laboratories (especially small ones). The already-high standards of quality management of all ISO-accredited and Swissmedic-authorized laboratories render IVDR law of little value, at least in Switzerland, while tremendously increasing the regulatory burden and associated costs. Eventually, patients will need to pay for diagnostic assays outside of the framework of their insurance in order to obtain a proper diagnostic assessment, which may result in social inequity. Thus, based on the risk assessment outlined above, the coordinated commission for clinical microbiology proposes adjusting the IvDO ordinance by (i) introducing an obligation to be ISO 15189 accredited and (ii) not implementing the IvDO 2028 milestone.

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confidence: 99%

“…This “health institution exemption” concerns, for example, their quality management system (QMS), risk management, performance evaluation, and justification of IH‐IVD use 2 . The first significant task for diagnostic laboratories at health institutions, compliance with Annex I, has been applicable since May 2022, whereas other implementation timelines are shifted based on the December 2021 amendment of the IVDR 3,4 …”

mentioning

confidence: 99%

“…2 The first significant task for diagnostic laboratories at health institutions, compliance with Annex I, has been applicable since May 2022, whereas other implementation timelines are shifted based on the December 2021 amendment of the IVDR. 3,4 The European Commission published official EU guidance on the health institution exemption under Article 5 (5) in January 2023, 5 but this document contains limited detail on how to fulfill the IVDR requirements for IH-IVDs. National competent authorities (NCAs), which perform inspections and enforce IVDR compliance in their Member States, can therefore be a valuable source of information on interpretation of this regulation for the diagnostic community.…”

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confidence: 99%

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Experience With IVDR Implementation in Three Diagnostic Laboratories: Messages to EU Health Institutions, Diagnostic Healthcare Payers, and Authorities

et al. 2023

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Critical Implications of IVDR for Innovation in Diagnostics: Input From the BioMed Alliance Diagnostics Task Force

Cited by 8 publications

References 7 publications

Targeted High-throughput Sequencing for Hematological Malignancies: A GBMHM Survey of Practice and Cost Evaluation in France

Targeted High-throughput Sequencing for Hematological Malignancies: A GBMHM Survey of Practice and Cost Evaluation in France

IVDR: Analysis of the Social, Economic, and Practical Consequences of the Application of an Ordinance of the In Vitro Diagnostic Ordinance in Switzerland

Experience With IVDR Implementation in Three Diagnostic Laboratories: Messages to EU Health Institutions, Diagnostic Healthcare Payers, and Authorities

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