Another European Gap that Needs to be Filled: Advanced Diagnostics

Accusations that Europe is slow to take advantage of advances in healthcare are a commonplace–and the melancholy evidence often supports the contention. Even the officials and politicians at the head of the European Union, which exists on the basis of determined optimism about the potential of its 27 member countries working together, are obliged to recognize there are failings that should be remedied. The EU's "new pharmaceutical strategy for Europe," now being gradually implemented, acknowledges that "though Europe’s response has demonstrated strengths, existing vulnerabilities have been thrown into sharp focus" by recent health challenges. "A new EU approach is needed to ensure we have a strong, fair competitive and green industry that delivers for patients, and which draws on the potential of the digital transformation of health and care, driven by technological advances in fields such as artificial intelligence and computational modelling," it has announced grandiosely.

"There is a growing consensus that policies need to be rethought so as to stimulate innovation, in particular in areas of unmet needs, and for pharmaceutical innovation to be more patient-centered, health system oriented and take account of multi-disciplinary requirements, such as in long-term care settings," accepts the strategy. But on one of the promising areas of development, the role of advanced diagnostics, it has little to say: no more, in fact, than a passing reference in the context of the campaign to tackle antimicrobial resistance, where it identifies the need to "draft evidence-based guidance on existing and new diagnostics."

A new review from the industry grouping representing many of Europe's smaller research-intensive companies sets out the case more eloquently for advanced diagnostics. "Despite the many scientific breakthroughs across European academic centers and hospitals, the adoption of advanced diagnostics and technologies in the clinic and healthcare systems is not a foregone conclusion, and the rate of adoption in Europe is falling behind that of other regions globally," laments Eucope.

Entitled "Developing an advanced diagnostics ecosystem in Europe: a proposal for change", the central argument of the review is that the value of advanced diagnostics is not sufficiently recognized, and as a consequence clinical practices are not keeping up with the accelerating cycle of innovation in novel diagnostics. In addition, in Europe it takes too long to bring advanced diagnostics to market, in processes that are "complex and fraught with uncertainty." To make matters worse, "essential clinical supporting infrastructure is lacking in Europe"–in terms of an appropriately trained workforce, data sharing and data storage infrastructure capabilities, or digital health recording within healthcare systems.

Among the downsides of missed opportunities in Europe, the review notes that advanced diagnostics have enabled the development of novel trial designs, which permit the testing of patients with multiple tumor histologies and/or tumor molecular aberrations–through master protocols comprising both umbrella trials and basket trials fall. Health technology assessment bodies in Europe are also slow to accept the benefits of advanced diagnostics or to fully appreciate their role, says the review. "HTA bodies should acknowledge the challenges of implementing traditional study designs for advanced diagnostics–as they are not fit for these technologies–and accept novel study designs (e.g. basket trials, umbrella trials, and retrospective studies) that demonstrate the clinical utility of advanced diagnostics and prioritize timely patient access."

"With a rapidly growing number of advanced diagnostic tests available to patients, serious consideration needs to be given to ensure a robust and healthy diagnostics ecosystem in Europe that allows innovators to thrive," the review argues, calling for infrastructure to support sequencing on a large scale, wider use of basic supporting digital infrastructure such as electronic health records across European healthcare systems, insufficient bioinformatics infrastructure and computational tools needed to interpret sequencing results, including data storage and periodic reevaluation of incidental findings that may attain clinical relevance over time.

One of the factors identified as hampering realization of the potential in Europe is that genomic tests have been performed only in public laboratories within hospitals, limited to the research setting, and largely focused on oncology. It is only recently that decision makers have begun considering commercial tests.

The review suggests that private–public partnerships can offer a route to faster adoption of advanced diagnostics in the clinical setting. It cites the case of Genomics England, with its interface and in-depth collaboration between NHS commissioning and technology companies. It also salutes the partnership agreed between the precision oncology company Guardant Health and the Vall d’Hebron Institute of Oncology in Barcelona, Spain, which is establishing the first Guardant-based liquid biopsy testing service in Europe. The opening of this service is expected to significantly increase the number of cancer patients identified as eligible for clinical trials based on available precision medicines and help accelerate research and development of the next wave of cancer therapeutics, claims the review.

Eucope, the industry association behind the review, with a heavy investment among its member companies in products that are designed to serve the growing possibilities of personalized treatment, concludes with a call for greater integration: "A coherent strategy for personalized medicines should articulate the approach to disease profiling and consider the integration of advanced diagnostics into clinical practice," it says.