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UK Issues Sweeping Genomic Medicine Report

NEW YORK (GenomeWeb News) – A UK advisory panel focused on advancing genomic medicine today urged the National Health Service to undertake a multi-pronged approach to unleash the potential of genomic technologies, while the Department of Health said that it plans to create a commissioning and funding structure for molecular tests for cancer.

The report, issued by the Human Genomics Strategy Group, lays out steps that the UK should pursue to realize the clinical possibilities of genomic medicine, which could be used to enhance clinicians' ability to determine disease risk and predisposition, to make more accurate diagnoses and prognoses, and to develop personalized therapies.

The report sketches the innovations in genomics that can be applied to clinical and diagnostic care — and the UK's investments in and commitment to genomics — and then proposes measures the government could take involving commissioning, data handling, public health issues, and education, which could support the adoption of these technologies.

In a statement today announcing the report, Health Secretary Andrew Lansley remarked on the new plan to develop a commissioning and funding structure for cancer-related molecular tests.

"This means there will be a formal structure — led by the NHS Commissioning Board — which will mean that more cancer patients will get access to these tests," he said.

"The promise of genomic technology, with its capacity to improve our understanding of the nature of disease and how our genes can inform our response to therapy, is immense but as yet developmental. The ability to use molecular testing of cancers to match individuals to the most appropriate treatment is revolutionary," Lansley explained.

Primarily because of its strong research culture and resources, the UK is well-prepared to begin pursuing the early phases of genomic medicine, but steps need to be taken to prepare for the broader penetration of genomics in clinical care and diagnosis, HGSG advised in the report, "Building on Our Inheritance: Genomic Technology in Healthcare."

Foremost, HGSG has recommended that NHS develop a plan for adopting genomic technologies, develop a central genomic data storage network to handle the vast amount of biological information genomic medicine generates, and begin developing commissioning plans and a service delivery model for genomics technologies.

To prepare citizens and healthcare workers for the advance of genomic medicine, NHS also should continue to develop education and training programs and make efforts to raise public awareness of genomic technologies and their benefits, HGSG recommended.

"Genomic technologies are more than just another innovation: they present a major step-change in medical practice and public health. They offer tangible benefits across the spectrum of patient care, including GP surgeries, mainstream clinical specialties, and highly specialist units," HGSG stated in the report. "And, with the pace of technological change at an unprecedented level, many uses of genomics are set to enter mainstream clinical practice within the next three to five years."

John Bell, chair of the strategy group, said in a statement that to maintain and build upon the UK's status as a genomics leader, multiple partners including NHS and the academic, industry, and research communities will need to undertake a concerted effort.

"Our recommendations to the Government lay out key steps that can be taken now and in the near future to realise this goal," Bell said. "Adopting the recommendations in our report would lead to further revolutionary developments in our ability to diagnose, treat and prevent disease, and I urge the government to consider these."

Delivering on the goals outlined in the report will require the government to develop standardized processes for establishing the clinical validity and utility of genomic tests and for the quality assurance of each test, test center, and technology.

To that end, HGSG recommends that the government develop a white paper that will set out its overarching policy direction on genomic technology adoption in the NHS and undertake health economics studies to quantify the costs and benefits of investing in genomic medicine.

The government also would need to set clear standards for genomics and clinical genetic testing within clinical pathways in order to create a universal process for healthcare professionals to request tests and receive results, HGSG advises. A bioinformatics infrastructure also will be critical to enable rapid, low-cost testing of many individuals' genomes against a database of known variants.

"To capitalize on the rapid development in sequencing technologies and to allow us to interpret genomic data accurately and in a clinically relevant way, the highest possible quality standards need to be in place around the management, storage, and use of data from research through clinical usage," HGSG advised.

The strategy group suggested that the government establish a central repository for storing genomic and genetic data and phenotypic data, and that it should provide biomedical informatics services and an open-data platform that could be built upon by small and medium-sized enterprises.

"We particularly support the proposal to link genomic data to patients' anonymized medical records through a secure national centre, which would create an unparalleled resource for research and diagnosis without compromising confidentiality or privacy. It is also important to develop medical informatics services that can make sense of complex genomic data, and to update professional training to meet the challenges of the genomic age," Mike Stratton, director of the Wellcome Trust Sanger Institute, said in a statement.

The authors of the report also suggest that the UK also will need to develop a legal framework to address the challenges posed by the availability of genomic medicine and to protect against abuses of genomic data. To that end, the group recommended that the NHS Commissioning Board take the lead on commissioning genetic and genomic services.

This would entail NHSCB establishing a network to deliver expert advice on the strategic development of genetic and genomic services and developing national tariffs for genetics and special pathology tests in order to ensure that the costs of genetic diagnostics is included in the clinical specialty pathway.

The NHSCB also would be tasked with developing, in collaboration with the UK Genetic Testing Network, the National Institute for Health and Clinical Excellence, and other partners, a process for evaluating the clinical validity and utility of all genetic and genomic tests and markers, and setting minimum standards for each. The board also would ensure that NICE Diagnostics assess the validity, utility, and quality of all new molecular tests, and that data on tests carried out by NHS-commissioned labs be made publicly available on national databases.

Lastly, the report urges the government to engage the UK public in efforts to promote greater understanding of genomics and what it means for healthcare.

The cross-government strategy group that created the report was set up in response to a 2009 report on genomic medicine from the House of Lords.