Last week, I cited the Horgan 2024 paper on the gap between medical guidelines and payor policy (here).
This week, at Linked In, Steven Haken flagged a 2022 paper -also by Horgan et al - that's equally timely (here).
The paper is, "The gaps between the new EU legislation on in vitro diagnostics, and the on-the-ground reality." (Clin Chem Lab Med, 2022, 61;224.) You'd be excused for having leafed past it in 2022, but now in 2024 with the FDA LDT tsunami, it's acutely timeline reading.
Open access:
https://repository.ubn.ru.nl//bitstream/handle/2066/290872/290872.pdf
Summary by Chat GPT.
Here are five key takeaway points about the 2022 Euro paper on the EU In Vitro Diagnostic Regulation (IVDR), which is now highly relevant given the new 2024 FDA regulations on lab-developed tests (LDTs) in the USA:
Regulatory Challenges and Delays: The paper highlights significant regulatory challenges with the implementation of the IVDR, including delays in processing approvals for in vitro diagnostics (IVDs). These delays, caused by insufficient infrastructure and the limited number of notified bodies (NBs), have led to a backlog in approvals and pose a risk to the continuous supply of essential diagnostic tests. The 2024 FDA regulations on LDTs in the USA may face similar hurdles if the regulatory framework is not adequately prepared.
Impact on Laboratory-Developed Tests (LDTs): One of the critical concerns raised in the paper is the impact of the IVDR on LDTs, which play a vital role in personalized medicine and rare disease diagnostics. The new stringent requirements under IVDR may lead to the discontinuation of essential LDTs, as they become commercially unviable under the new regulatory framework. This scenario is directly relevant to the USA's experience with the FDA's new LDT regulations.
Innovation at Risk: The paper discusses the potential stifling of innovation due to the IVDR's rigid regulatory requirements. The uncertainty and complexity of the new rules could discourage the development of novel diagnostics, particularly in niche areas like molecular oncology and genetic testing. This concern is equally applicable to the USA, where the new FDA regulations might hinder the progress of cutting-edge diagnostic technologies.
Inconsistent National Implementation: The IVDR has been inconsistently implemented across EU member states, leading to disparities in regulatory enforcement and patient access to diagnostics. The lack of uniformity in regulatory practices across the EU has created confusion and uncertainty. As the FDA rolls out its new LDT regulations, the USA could face similar issues if there is a lack of coordination and standardization across states.
Recommendations for Improvement: The paper emphasizes the need for greater collaboration between regulators, manufacturers, and the diagnostic community to address the gaps in the IVDR. It calls for increased capacity for NBs, streamlined certification processes, and more transparent guidance to ensure the continued availability and innovation of diagnostics. These recommendations are also relevant to the FDA's approach to regulating LDTs in the USA, highlighting the importance of stakeholder engagement and regulatory clarity.
These points provide a comprehensive overview of the critical insights from the 2022 paper, which now serves as a valuable reference for understanding the potential challenges and opportunities posed by the new FDA regulations on LDTs in the USA
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Steven Haken also flagged an important review by Hofmarcher et al, 2023, on the value of precision medicine in NSCLC - here, here.
