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BIVDA Report Outlines UK Access Barriers to Genetic, Genomic Diagnostics

NEW YORK – Patient access to genetic and genomic diagnostics (GDx) in the UK is limited despite the country's significant contributions to genomic innovations, according to a new white paper commissioned by the British In Vitro Diagnostics Association (BIVDA) and written by Charles River Associates.

"Despite the availability of an increasing quantity and quality of GDx, data shows these tests are underutilized across many indications," the paper noted about the UK's adoption of GDx technologies.

The report lists a number of challenges and barriers the country faces in expanding these services. They include a lack of centralized guidance to apply for funding for genomic technologies and a shortage of infrastructure to educate physicians and patients.

The paper, titled "Leveraging partnerships to realize the UK’s potential in genomics," also examined various partnerships between the UK's health system and the diagnostics industry in order to understand the problems plaguing patient access.

Highlighting an example of a successful partnership, the authors said NHS's collaboration with cancer diagnostics firm Grail to pilot the adoption of a new cancer early detection test in 140,000 patients across England would help inform the future of cancer screening in the UK.

"Partnerships can provide a cornerstone for establishing new GDx infrastructure within the NHS, with companies able to provide capacity and capabilities that would be too resource-intensive for individual NHS trusts and laboratories to establish," the report said.

However, fostering such partnerships alone to resolve all challenges associated with integrating novel GDx routinely and sustainably into clinical practice across the UK is not enough, cautioned the report. "Beyond supporting the growth and expansion of partnerships, targeted policy intervention is also required to address the root causes of the impeded adoption of GDx technologies in the UK health system and support routine patient access," the authors wrote.

Some of the recommendations for policy-level interventions included better implementation of a new regulatory framework covering GDx, greater clarity and guidance on pathways into regulatory approval, and providing accessible and appropriate education for clinicians, patients, and decision makers.

The report further pointed out the benefits of a wider adoption of GDx, noting that it would lead to rapid and accurate diagnoses across rare diseases and cancer and can ensure appropriate and targeted treatments. It could also minimize adverse drug reactions that currently account for 6.5 percent of UK hospital admissions and help improve public health outcomes.

"Finally, widespread adoption of GDx into society has the potential to deliver profound economic growth across the entire UK, creating new jobs and increasing the number of economically active individuals," the report said. 

Jennifer Harris, director of research policy at the Association of the British Pharmaceutical Industry, said in a statement that it is essential the government delivers on the commitments it made in the Genome UK plan that was published in 2020. Late last year, the UK Department of Health and Social Care said it would invest £175 million (about $215 million) in genomic studies as part of the Genome UK national genomic healthcare strategy.

"Doing so will transform care for patients, help the NHS address the pressures it faces, and position the UK as the destination of choice for genomics research, development, manufacturing, and treatment," she said.