Safety first: But IVD legislation must also promote innovation and access

By European Alliance for Personalised Medicine (EAPM) Executive Director Denis Horgan; EDMA Public Affairs Officer Magdalena Kalata; Roche Government Affairs Manager Rebecca Jungwirth; Netherlands EAPM Patient Representative Tom Van der Wal

The field of in vitro diagnostics, or IVDs, is highly technical and complex, and its regulatory framework at EU level is no different.

The legal frameworks for medical devices and IVDs are currently under revision, with the intention of ensuring that medical devices serve the needs and ensure the safety of European citizens. Yet despite the parallel processes of revision, medical devices and IVDs are very different in many aspects, making the rerevisions even more complex.

IVDs are non-invasive tests used for diagnosis, screening, assessing and monitoring. They offer information about a person’s health status – such as blood glucose levels or cholesterol - but do not provide treatment. In more complex examples, IVDs can provide doctors with the necessary information to help personalise a patient’s range of treatment. Especially in the latter instance, IVDs can optimise patient outcomes and have a key role to play in personalised medicine.

In the emerging field of personalised medicine, high quality diagnostics are vital to providing accurate and reliable information for making the correct diagnosis, allowing practitioners to deliver the right treatment to the right patient at the right time.

Companion diagnostics are precisely this type of IVD, providing the potential to more effectively treat patients by targeting therapies and avoiding ineffective treatments or adverse events. This important and unique role within personalised medicine strongly links companion diagnostics to their counterpart companion drug – simultaneously distinguishing them from other IVDs.

For example, gene sequencing of a patient’s disease may enable doctors to acquire more information on the severity of the disease, its specific attributes or hybrid characteristics, as well as to distinguish patients who will benefit from a treatment. Genomic and genetic testing methods thus have the potential to produce faster and more reliable results, propelling personalised medicine forward.

However, developing an accurate and reliable diagnostic is challenging and expensive, as is finding a predictive biomarker, while the process of approval for co-dependent technologies – therapies and companion diagnostics – is complex and long. Problems in the approach include a lack of coordination and issues surrounding reimbursement, problems that are still unresolved and should not be complicated further.

When it comes to the approval of a new in vitro diagnostic for the European market, at present the manufacturer must assign the device to the relevant risk category. Companion diagnostics to evaluate genomic biomarkers in cancer would be classified as low risk in the current classification system. In this case, the manufacturer self-certifies conformity once the device meets the requirements specified so as to ensure no compromising of a patient or user’s health and safety.

These IVDs must also be designed to achieve the performance specified by the manufacturer and as such, manufacturers must maintain a systematic review of their products, notifying the national competent authorities of any incidents or recalls that result, or could have resulted, in death or serious injury. For higher-risk IVDs, additional and more comprehensive requirements already apply, but under the new legislation, the whole system will be reworked.

The new proposal for IVDs no longer classifies companion diagnostics as low risk and no longer allows for their self-certification. Companion diagnostics will instead soon be classified as having high individual risk or moderate public health risk and will need to undergo conformity assessment by a notified body. The level of clinical evidence required will also increase and, for instance, companion diagnostics will need to demonstrate the clinical utility of the device for its intended purpose.

The European Alliance fir Personalised Medicine (EAPM) believes that new EU IVD legislation should establish a system for companion diagnostics that ensures effectiveness and patient safety alongside promotion of innovation and early patient access. The revision is a clear opportunity to strengthen the current approval system to these ends.

EAPM is also strongly of the opinion that a five-year transition period for IVDs is needed for manufacturers to be able to fully comply with the various new requirements and to put all of the necessary procedures in place.

Anything less than a five-year transition is simply not feasible due to the comprehensive changes required of manufacturers and importers, Notified Bodies, Competent Authorities, reference laboratories, the European Commission and other related organisations.

The need for a five-year transition period was demonstrated in Australia, when the implementation of a similar legislation required an extension from an original three-year transition period to four years and, as of 29 May 2014, to five years.

EAPM is fully behind legislation that ensures better safety, access to treatment for Europe’s patients, and promotes innovation, but maintains that a sensible balance must be reached to achieve all of these goals.

Legislators have a difficult task ahead to ensure that the lines between the regulating of the therapy and the diagnostic are not muddled, but with improved patient outcomes and better access at stake, it is a critical one.

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