The Academy of Medical Sciences (AMS) has today released a new report, Realising the potential of stratified medicine, which says progress is being hindered by unsuitable regulatory and pricing systems.
Stratified medicine, more usually referred to as personalised medicine (see our free guide for more information), is the assessment of biological features in order to inform preventive or therapeutic health care tailored to an individual. For example, selecting a cancer drug that specifically targets a key genetic feature of a patient’s tumour, or determining a drug dose based on genetic variants that affect how the patient will metabolise the drug. Although still in its infancy, this field of medicine holds enormous potential to improve the safety and efficacy of treatments and refine the accuracy of risk prediction and preventative interventions.
A similar approach can also be used to more accurately stratify populations into different risk categories for screening, for example identifying women at the greatest risk of breast cancer.
However, the new AMS report finds that current approaches to clinical development, regulation, pricing and reimbursement have not kept pace with scientific developments and are holding back clinical implementation of personalised medicine applications. The report emphasises the need for reliable and accurate diagnostic tests such as companion diagnostics for biologically targeted drugs to underpin personalised medicine (a view repeatedly advanced by the PHG Foundation in recent years), and for the creation of incentives to support the generation of evidence for such diagnostics.
The AMS also highlight the need for suitably harmonised databases and biobanks and calls for an international effort to ensure that high quality whole genome sequencing data is stored; a new global alliance (of which the PHG Foundation is a member) has already been established to agree on standards for sequence data storage and sharing (see previous news). Finally, they call for concerted action to address these barriers and support clinical implementation.
Comment: Personalised medicine is a key aspect of genomic medicine and an ongoing area of work for the PHG Foundation, building on our 2011 report Next Steps in the Sequence, which highlighted the need for new capacity in data storage and analysis. Professor Sir John Bell, who chaired the AMS group behind the new report, said that implementation would ‘rely on the collection, storage and analysis of significant amounts of data’ requiring ‘the development of appropriate infrastructure and working practices to provide the high quality data’. Last week a new company owned by the UK Department of Health, Genomics England, was launched with a mandate to oversee the £100 million investment in genome sequencing in the NHS, including effective commercialisation of this vast new data resource (see previous news).