If the pandemic has shown us one thing, and if we are to learn just a single lesson from the experience of 2020/21 it has to be around the importance of diagnostics in managing infectious diseases. Now, it is true that you cannot test your way out of a pandemic, but, you can at least use testing to guide your response, making sure that your response is both proportionate and effective.

Behind the now sadly familiar scenes shown throughout the world of full ICUs, of patients being proned, and mass swabbing stations staffed by PPE wearing health workers, there is a network of diagnostic laboratories. Each laboratory with a team of clinical and scientific experts in the diagnosis of infectious diseases. With this team, when applied to the issue of antimicrobial resistance, they are the keyholders for our last line of defence against the next microbial pandemic, Antimicrobial Resistance, for which we may find we have no effective treatment.

We have seen in the pandemic, as it has torn across the globe, the need for rapid access to the most appropriate test to identify positive cases, the importance of identifying new variants, and the delivery of new and innovative technologies to enable delivery of testing at scale. We have also seen the expansion of home testing on a scale that would hitherto be unthinkable to trace and trace the disease.

A final, perhaps hidden, dramatic change that we have seen is the interconnectivity of the data produced, this is perhaps the most significant change in terms of changing the UKs ability to respond to pandemic whatever its origin. This change has been unseen by many, but has shown huge benefit as demonstrated by the fact that much of the world’s understanding of the genomic changes in the virus comes from the UK.

We have seen in this pandemic considerable change to meet the response to a serious threat to the health and wellbeing of our population. It poses an interesting question, why have we struggled with the equally serious AMR challenge which may have a similar impact globally and has been known about for decades?

Where are we now?

Currently in England over 95% of patient journeys involve diagnostic tests. The NHS spends over £6bn a year on diagnostic services and with this carries out an estimated 1.5 billion diagnostic tests. 1.1 Billion of these tests are within Pathology costing £2.2bn. This equates to just 2% of the total budget of the NHS. ¹

Healthcare in the UK is traditionally reactive rather than pro-active. Outside of screening programmes, patients wait until they are symptomatic before their diagnostic journey begins. Many hospital microbiology laboratories do not currently provide a routine 24/7 service, workforce shortages and total activity prevents many services from being able to sustainably and securely provide these services. As has been discussed in previous blogs in this series, the availability, sensitivity and speed of tests that can rule in or rule out the need for antimicrobial use are not yet available.

The product of this is a reactive service, slow in achieving targeted therapy, service that does not meet the needs of the ambition set out by Lord O’Neil, but also leaves us somewhat short of what is truly needed to tackle the issue of Antimicrobial resistance and good antibiotic stewardship. Any effective AMR stewardship approach needs the time between symptoms and targeted treatment to be as short as possible.

Where do we need to be within a generation?

Earlier, smarter diagnosis is vital in predicting and controlling the spread and improving the outcome of any disease, as is the need to give public health and healthcare providers all the tools they need to ensure the best possible patient outcomes. All this being in place it would then be possible to target services that make best use of capacity and resources. When this is combined with public health surveillance activities this can rapidly limit and prevent potential outbreaks and improve our AMR stewardship.

A generation is too slow for the improvements needed in the laboratory infrastructure. For the last 20 years the strategic goal across much of the UK has been to network medical laboratories.^2,3,4 This has been to ensure the right technology and the right test is available for the right patient at the right time. Networking of services, which also includes centralisation of some services allows for better use of our limited workforce, ensures we are better able to afford the right technology and allowing laboratory services to run routine services 24/7. Our goal should be to provide maximum information as early as possible, which also means the ability to share data and Information across the healthcare system seamlessly, allowing for information to be shared with any healthcare professional that requires it. Once this was seen as a challenge too far, but the need to share pandemic data saw laboratories, healthcare systems, epidemiologists and data scientists all connected into a single data feed from, tracking the spread, to monitoring variants, to assessing vaccine performance, so the precedent has been set and it is achievable.

How do we go from here to there?

The biggest improvement that networking can deliver is sharing data.

Much of the stride forward in pro-active diagnostics comes from using population data. This use of big data and AI will enable clinicians based in the most suitable setting to refer patients into the correct clinical pathways or enable patients to access rapid diagnostic centres based upon the symptoms and most useful diagnostic tests or allow a community health teams target individuals who will most benefit from their support, and equally as importantly signpost individuals that do not require healthcare services. For infection sciences this means, who to treat, when and with what. The saving in clinical time by working smarter will support the work of clinicians and scientists in identifying the disease earlier, monitoring the optimum targeted treatment options and outcomes. These improvements would also be a route to resource further research into antimicrobial agents and maintaining the diagnostic approach.

Getting to a point when we have optimised the laboratory services, running 24/7 services to rapidly support the decision-making around the most appropriate treatment for patients will put us in a position where all patients will receive the required diagnostic tests to support a personalised approach to their care. The output, greater than for an individual who receives better targeted care, is that we will be far better placed to guarantee the appropriate use of antibiotics. This digital and AI capability will give the life science sector access to considerable data, so far unavailable at the scale envisaged and with that comes the opportunities to learn more, faster with greater benefit in the fight against AMR.

Resources:

1. The Future of Diagnostics Delivery in the UK Report (roche.com)
2. Report of the Review of NHS Pathology Services in England (networks.nhs.uk)
3. 160518_Final paper_with cover.pdf (amr-review.org)
4. NHS England » Pathology networks

David Wells is recognised as being one of the 100 powerful advocates for pathology in the global community by the Pathologist magazine in 2018, 2019, 2020 and again 2021. Until June 2021 David was leading NHS England and NHS Improvement Pathology consolidation programme, seeking to deliver efficient, high quality pathology services across England. Pathology services are embracing this considerable change at a pace not previously seen, with pathology service reconfiguring as proposed on track, with Industry reconfiguring likewise to match the new models of delivery.

David was also leading the NHS England`s laboratory response to COVID-19, managing technology deployment, capacity, funding and workforce ensuring that all capacity requirements are met. Advising ministers and providing policy and strategic direction.

In recognition of this work and the work in transforming England’s pathology services the Royal College of Pathologists awarded David Honorary fellowship of the college in 2020

David has a diverse experience of providing and leading pathology services to primary, secondary and tertiary care across all pathology disciplines. Trained at Addenbrookes Hospital qualifying in December 2000, followed by a number of roles including Great Ormond Street Hospital as the Lead Healthcare Scientist for GOSH, covering the entire Healthcare Science workforce, the first person to hold this post and as Director of Operations (and CQC registrant manager, responsible for diagnostics services covering several million people)  at Viapath covering Kings College Hospital and Guy’s and St Thomas’ Hospitals at the time one of the UK’s largest networked pathology services.

Having worked in both the public and private sector David has developed considerable experience is identifying business opportunities to drive growth and development of services to drive both an economic benefit but also commercial differentiators to establish both brand and brand confidence. This from the perspective of attracting new customers but also to attract and retain workforce in a competitive recruitment market.

David has been an elected Institute of Biomedical Sciences (IBMS) council member for the London Region. David has also represented the IBMS on NICE diagnostic advisory panels, and various national forums including an observer on the Royal College of Pathologist Council and in the Parliamentary and Science committee. David is now the Chief Executive for the IBMS, leading the professional body of approximately 20,000 members in 71 countries promoting biomedical science, training and educating the current and the next generation of Laboratory scientists.

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Initial response from BSAC

David Wells is eminently qualified to provide an oversight of the importance of microbiology laboratories in tackling antimicrobial resistance (AMR). Before taking up his current role as chief executive of the Institute of Biomedical Sciences, he headed the NHS England/Improvement initiative to network pathology laboratories, so his views on how microbiology services are central to managing resistance are based on sound foundations.

David describes the COVID-19 pandemic and the global rise in AMR and highlights the difference in support for the laboratory effort needed to meet both these challenges. The dramatic spread of COVID-19, its obvious lethality and the consequences for nearly all aspects of life, have driven the urgent laboratory response. The more insidious nature of the AMR pandemic and the subtle and complex variation in its manifestation should not be allowed to deceive policy makers into thinking resistance is less of a threat. On the contrary, the stealth with which resistance spreads obscures an important point; eradication requires far greater effort than prevention.

Yet, the shortfall in effective laboratory effort to counter AMR is readily apparent.  The mainstay of microbiology laboratories throughout the world is long-drawn-out culture of bacteria on agar plates – a 19^th century technology – meaning that clinicians have to make treatment decisions 24 to 48 hours ahead of laboratory results.   This creates a dilemma; do prescribers opt for broad-spectrum antibiotic treatment that, in the short term,  is more likely to cover the infecting pathogens but in the longer term will accelerate the rise of resistance, or should they gamble with narrow-spectrum antimicrobials  that may not hit the target but cause less resistance damage? The solution is a rapid test that tells clinicians the answer when treatment decisions have to be made.

This requires a dramatic shift in laboratory practice to a molecular biology-based approach.  Although some diagnostics manufacturers have marketed rapid tests, their uptake by clinical laboratories has been limited and this dissuades investment in further test development. Molecular tests carry a hefty price tag and require laboratory testing skills and platforms that, until the pandemic, were absent from many labs. The COVID pandemic has been a boon for the introduction of molecular tests into microbiology labs; nucleic acid amplification platforms are now commonplace, biomedical scientists have been given a crash course in using this technology and, perhaps most importantly,  healthcare payers now have experience of the less-apparent benefits of molecular tests to set against their more obvious costs .  It would be a bright silver lining if a legacy of the COVID-19 pandemic is to put microbiology laboratories in a better position to confront AMR.