#Advanced diagnostics trial

Essential clinical supporting infrastructure is lacking in Europe.There is a lack of pathways for appraisal that are time-bound and flexible and that can accommodate the unique characteristics of advanced diagnostics. The time to market for advanced diagnostics is too long, complex and fraught with uncertainty.Funding is insufficient and support not well suited to increase their role in the clinical setting, resulting in clinical practices not keeping up with the accelerating cycle of innovation in novel diagnostics. The value of advanced diagnostics is not sufficiently recognised.There are several factors to explain this: Investment in genomics technologies and applications provides further societal benefits beyond our health systems, with dynamic advanced diagnostic “ecosystems” stimulating innovation, growth and employment, in particular in mature healthcare and biotechnology sectors.Įurope has been the source of much of scientific development in genomics, however despite the number of scientific breakthroughs in research programmes across academic centres and hospitals, the adoption of advanced diagnostics in the clinic and healthcare systems is still limited in scale and the overall rate of adoption in Europe is falling behind that of other regions globally. Today we can deliver the right treatment for the right patient at the right time – with widespread adoption, the potential is enormous to derive exponential benefit to healthcare systems alongside more targeted and efficient use of resources. These innovations facilitate earlier diagnosis of disease, improve the prognosis of disease outcome and enable targeted therapeutic interventions based on an unprecedented understanding of the underlying molecular characteristics of patients.

#Advanced diagnostics trial

They are used for a variety of clinical purposes that span both research and clinical decision-making, including: screening for disease, diagnosis, prognosis, therapy selection and prediction of treatment benefits, monitoring risk of recurrence as well as support in clinical trial designs and discovery of genomic predictive biomarkers.Īdvanced diagnostics represent a paradigm shift in medical care, primarily because of the vast amount of relevant information they generate and their wider uptake in healthcare systems carries significant benefits. “Advanced diagnostics” exploit the improved understanding of genomics, that is the study of genes and their functions, and related techniques. The group aims to facilitate a dialogue around these technologies in order to make decision-makers and stakeholders more aware of their value and work towards fit-for-purpose assessment frameworks and clear and effective pathways for reimbursement of genomic testing. The Genomics Working Group is made up of advanced diagnostics companies that have come together to ensure Europe will be able to draw benefit from the significant advances that have been made in genomic testing.