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Perspective: How Biopharma Can Navigate EU IVDR to Keep Clinical Studies on Track

By Foundation Medicine

In the seven years since the European Union announced new in vitro diagnostics regulations, commonly known as IVDR, there has been significant pushback and concern by pharma companies that are worried about delayed clinical trials and barriers to patient access to new treatments.

After IVDR went into effect in May 2022, one survey by the European Federation of Pharmaceutical Industries and Associations showed that between 82 and 160 trials that involved the use of IVDs were delayed due to the requirements to comply with IVDR for the clinical performance studies — and the collective perspective on the situation among respondents was that the situation would only get worse.

But with advance planning and a diagnostics partner with demonstrated regulatory expertise, it is possible to navigate EU IVDR requirements with confidence and keep clinical trial timelines on track.

Start IVDR Submissions 6-12 Months Ahead to Keep Clinical Studies on Track in Europe

With the centralized EUDAMED pathway not expected for years, the most pressing need for many pharma sponsors navigating IVDR is a diagnostic partner to support starting trial sites in Europe country by country for active or upcoming clinical programs.

Foundation Medicine, the global leader in approved companion diagnostic indications, has successfully activated clinical performance studies in 20 European countries, complying with IVDR requirements and supporting pharma partners in their global clinical operations strategy.

One key to success is starting early. Planning six to 12 months before expecting the first patient in (FPI) should allow a pharma sponsor to manage the disparate submission requirements and review timelines that vary by country.

A graphical representation of the timeline for an interventional clinical performance study application under IVDR Article 66. The process starts with an Ethics Committee Opinion from each EU Member State, followed by an Administrative Review by the EU Member State. The sponsor then has a period for response, leading to an EU Member State Response on the 'Golden Path'. After a 'validation date' where the application is deemed complete, a Substantive Review by EU Member State follows. The cumulative time for the Ethics Committee Review is approximately 1 to 3 months, while the National Competent Authority Review is around 2.5 to over 4 months, plus clock stops, with a note that it could extend to over 6 months in some countries. The document cites MedTech Europe's Clinical Evidence Requirements and includes a footer noting copyright 2024 Foundation Medicine, Inc.

For example, the process of a clinical performance study authorization can be relatively quick, as in Spain where Foundation Medicine has seen approvals come through in as quickly as three months. But this is not the norm, and it often takes longer, as in Italy where it commonly takes up to eight months. Extensive experience with various national competent authorities (NCA) has enabled Foundation Medicine to expedite clinical study start-up timelines. Knowing what to expect provides clarity to a pharma sponsor about which trial sites to activate first and which to plan further out.

Know the Difference: Notification or Authorization?

The type of clinical performance study also matters for determining what regulatory pathway will be required — either authorization or notification — as well as the documents required and the timeline to expect.

An authorization is required for any performance study that requires fresh sample collection — like surgery or a blood draw — solely for the purpose of the performance study, interventional studies, or those where the conduct of the study involves additional invasive procedures or other risks to the study subjects. These can take more than six months to obtain in some countries.

A notification, on the other hand, is much faster in most countries, with a standard 10-day notification period for performance studies that use only leftover samples. However, the requirements for ethics committee review should also be considered when planning for the study. Some countries, such as Hungary and Sweden, require a 60-day ethics committee approval for these studies, emphasizing the importance of early planning.

To add to the complexity, some countries may view a particular study design or clinical trial procedure as needing only a standard notification while others require a full authorization.

An experienced diagnostics partner can support pharma sponsors with both authorizations and notifications.

Planning Ahead for Potential Changes in the European Testing Landscape

While the majority of biomarker testing in Europe today is done using in-house tests at hospital labs and institutions, the new requirements under IVDR may lead to an increase in the adoption of “send out” or centralized testing platforms based on the need for smaller institutions that will be required to spend and allocate resources to meet the validation standards required by IVDR.

One survey showed four options that labs may consider under IVDR, and the proportion may vary by country based on country-specific factors and needs:

  1. Labs that build or validate in-house testing to meet IVDR requirements.
  2. Labs that use IVDR-approved panels when using commercial testing in clinical care.
  3. Labs to shift from in-house testing to send-out or centralized testing.
  4. Labs that rely on anticipated lack of enforcement of IVDR requirements.

An informational slide on the impact of IVDR (In Vitro Diagnostic Regulation) implementation on testing dynamics in Europe. The title 'Testing Dynamics May Change in Europe Following IVDR Implementation' is followed by a statement that to overcome IVDR burden, market research suggests some small-to-medium sized labs may transition to send-out options. There are four options for lab under IVDR: 1) Build in-house infrastructure, 2) Only use IVDR panels when using commercial testing, 3) Move to centralized model/send-out, 4) Rely on anticipated lack of enforcement. Each option has a corresponding rationale and demographic likely to pursue it. At the bottom, there are three footnotes citing sources for the data provided and a footer that includes copyright 2024 Foundation Medicine, Inc.

Centralized labs, particularly those with a presence in Europe, can support patients and testing through this expected transition; Foundation Medicine operates a lab in Penzberg, Germany, and recently announced a technology transfer of liquid biopsy testing to the Institute Gustave Roussy in France.

Another key part of supporting patients under IVDR for any IVD test, in-house or centralized, will be to acquire the appropriate IVDR CE certificate, a requirement for commercial testing that will be effective in Dec. 2028. Some tests have already gone through the full conformity assessment process and achieved  IVDR CE certificates as approved companion diagnostics — Roche’s PD-L1 immunohistochemistry test as a CDx for immunotherapy was the first to do so, in January 2023.

Foundation Medicine is now the first company to announce it has submitted its centralized NGS platforms for tissue and liquid biopsy for IVDR review, with the intent to pursue approval of both tumor profiling and companion diagnostics claims for reporting upon launch well ahead of the 2028 effective dates.

The goal of IVDR is to improve public health and protect patients, in part by demanding that the IVD tests used to identify patients for clinical trials meet certain quality standards. Despite some of the challenges since its initial rollout, there are diagnostic partners with experience today that can support both now and in the future

For more information, please visit Foundation Medicine's website to read more about its Biopharma Services portfolio.

This sponsored content is provided by an advertiser and published in collaboration with the GW Custom Solutions Group, a division of GenomeWeb. The content was not produced by the editors or reporters of GenomeWeb, 360Dx, or Precision Oncology News, and does not represent the views of these publications or GenomeWeb's parent company, Crain Communications Inc.