The future of molecular testing within the UK


This is the first of a series of articles on molecular testing centralisation in the UK outlining the landscape as well as its impact on patient treatment.

Molecular testing centralisation within the UK has been making steady progress since its announcement in 2018 by NHS England. It was designed to enable equity of access to top of the range technology and expertise, ensuring “the best possible diagnostic and clinical outcomes”1 … all at an affordable price. The NHS also claims it will be able to leverage centralisation for research and development purposes on behalf of taxpayers and the wider economy. This reality is not enormously far off, however, the drawn-out process of centralisation so far has led to uncertainty, delays in testing turn-around times (TATs), reimbursement issues and downstream effects on patients. These issues are hoped to be resolved by the eventual completion of centralisation which will become more efficient as engagement from the respective networks increases. The test reimbursement issues should also be settled when central funding for tests on the National Genomic Test Directory is given to the Genomic Laboratory Hubs (GLHs), possibly by April 2020. Some funding, however, will still be allocated to individual hospitals for certain tests and biomarkers, as part of the “exclusion from tariff” reimbursement route2. It is clear that further developments in transport and digital infrastructure alongside reforming NHS testing guidelines will be necessary to support centralisation going forward.

There are NHS programmes currently in place which have the potential to meet these challenges going forward. The Get It Right First Time (GIRFT) NHS Improvement initiative is one such programme. GIRFT’s aim is to improve patient care and outcomes by reducing unnecessary tests, procedures and treatment whilst simultaneously saving costs. They work closely with NHS England to ensure their recommendations are reflected in updates to national guidelines. In theory, reduction of testing to ensure only the right tests are ordered at the right time for the right patients will lessen the burden on the GLHs and improve TATs.

Further, NHS England and NHS Digital (as part of the Long-Term Plan) are developing the IT infrastructure of the NHS to counter the increase in distances from hospitals to the laboratories amongst many other issues within the NHS. The Digital First report3 was released in 2014, outlining how the NHS had begun to digitise pathology and how it planned to continue to do so. Some services proposed in the report such as NPEx (the National Pathology Exchange) are currently used by 70% of hospitals in the UK4. It is a service for ordering and receiving pathology test results from a laboratory and is highly successful. Further, they outlined in 2018 a plan for an NGIS (National Genomics Informatics System) to make genomics more digitised alongside pathology, to roll out in time for the molecular testing centralisation. It was planned that NPEx would combine with NGIS to support centralisation, however, its progress has been stalled by further delays.

Furthermore, the NHS announced in 2018 five new centres of excellences for AI and Digital Pathology5. These centres are hoped to help hospitals make scans and biopsy images digital to cut down on manual reporting times, as well as develop the AI algorithms for patient treatment pathways. Digital Health London also announced a £50 million fund that NHS trusts can bid for a portion of to develop their own digital capabilities. It is clear therefore, that NHS England is committed to the medical digital revolution and it does provide a promising future indeed for molecular pathology centralisation and the NHS in general.

Despite this promise there are concerns with centralisation going forward including the speculation that it may lead to a migration of expertise or a ‘brain drain’. This problem may be alleviated by digitisation and the development of Virtual Tumour Boards. These would allow experts from various centres and departments to discuss patient scans through a secure video conference technology. Security concerns and lack of investment, however, has stunted its development. It is also thought that with the advancement of testing machinery enabling smaller, quicker and cheaper machines there could be a decentralisation effect seen further down the line. This could in turn cause another transition period of uncertainty, delayed TATs and downstream effects on patients.

The enormous promise of “the best possible diagnostic and clinical outcomes” has not quite come to fruition...yet. There is no doubt, however, that NHS England will eventually succeed with centralisation, with initiatives supported by NHS Digital and NHS Improvement paving the way. 

If you are looking for more information on molecular testing centralisation and how IPBA can help you with your strategy to enable better and broader patient access to biomarker testing, do get in touch. Look out for our next article in the series, a deep dive on the different level of centralization and challenges within each hub.

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Joe Joseph

Inflection Point Biomedical Advisors