Personalized medicine: Regulating companion diagnostics

*Clare Sansom reports on why this is a key time for regulating diagnostics*

Clare Sansom reports on why this is a key time for regulating diagnostics

Personalized medicines are normally prescribed along with diagnostic tools-so-called "companion diagnostics"-that enable the most appropriate patients to be selected.

Tight regulation of diagnostics is obviously necessary, but the rules for such regulation are different from those for drugs and, in some cases, are still developing.

In the UK, the responsibility for regulation rests with three independent agencies: the MHRA, NICE and BIVDA.

Eddie Blair, managing director of Cambridgeshire-based Integrated Medicines Ltd. and chair of the Innovative Medicines Advisory Group, met representatives of these three regulatory agencies to discuss recent developments in regulating companion diagnostics.

This is a brief summary of his findings.

The MHRA is the "competent authority" charged with translating the EU's In Vitro Diagnostic Medical Devices (IVD) directive into UK law.

If a companion diagnostic is to be sold alongside a drug, it must be CE marked as meeting all essential safety requirements.

There is no need, however, to so mark a test that is only to be used in clinical development.

Diagnostics are evaluated alongside the medicines with which they are designed to be used, and the timescale for evaluating them is similar to that for medicines.

Details of the information needed when submitting a novel diagnostic are consistent throughout the EU and are available from the European Medicines Agency website.

The IVA directive is currently under review, and people are encouraged to submit concerns about current practice as part of the consultation process.

NICE is not the initial regulator for either medicines or diagnostics; it is best known for its role in evaluating existing medicines for quality and cost-effectiveness.

However, its role in assessing diagnostics is increasing through Medtech programs for assessing medical technologies (EO) and diagnostics (DA), respectively.

Companion diagnostics may, but need not, be evaluated with medicines that they were developed alongside.

Diagnostic technologies are sent to the DA program by the NICE Medical Technologies Advisory Committee, where they also are evaluated for cost-effectiveness and clinical effectiveness before, if successful, being recommended for adoption by the NHS.

Evaluation for cost-effectiveness must take into consideration the cost of administering the diagnostic procedure.

The timeline and guidelines for submitting a diagnostic to NICE for evaluation are available from the NICE website.

Although NICE is a UK body, it is becoming increasingly involved through NICE International in supporting the regulatory procedure, including those for diagnostics, in other countries. (For more on NICE's international role, see HTAs go global: What it means for market access'.)

The British In Vitro Diagnostics Association (BIVDA) brings together UK-based manufacturers and distributors of diagnostics.

Its role in regulation is mainly to provide expert input into the EU's regulatory process via its membership of the European Device Manufacturers Association.

It is therefore collaborating closely with its sister bodies across Europe on the current revision of the EU IVD directive.

BIVDA also works alongside other industry organizations, such as the Association of the British Pharmaceutical Industry, to provide policy advice to the UK healthcare sector.

In particular, its collaboration with the pharmaceutical industry is becoming closer with the advent of companion diagnostics.

It sees changing the current, inflexible rules for evaluating the cost and value of diagnostic tests as a pressing need for the industry, and NICE as the most appropriate body to deal with this.

All three agencies agree that this is a key time for regulating diagnostics, as the revision of the IVA directive that is currently under discussion will play an important part in deciding the future direction of companion diagnostics.

They also recognize that the industry is becoming a global one, and UK- and even EU-based bodies will need to work more closely with their counterparts on other continents.

For more on companion diagnostics, and for all the latest advances in personalized medicine, join the sector's key players at Personalized Medicine & Diagnostics Europe on March 9 and 10 in London.

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