Considerations in developing distributed diagnostics

Distributed diagnostics add value for patients, healthcare systems and wider society in a surprising variety of ways.

In this final part of our series, we look at health economics and the less commonly measured benefits that can be expected to drive further adoption of distributed diagnostics.

Healthcare funding model and further distributing diagnostics beyond core labs

While the advantages of distributed diagnostics are clear, the uptake and usage of any intervention, including diagnosis is often affected by the economics of healthcare.  

In Switzerland, Norway and the Netherlands, for example, primary care physicians regularly perform CRP testing for respiratory tract infections because POC testing is reimbursed. However in in Spain, Italy and the UK, physicians must cover the cost of instruments and supplies out of their budgets and hence CRP testing is not widely performed. This disparity is also perhaps reflected in the rate of antibiotic prescribing for respiratory tract infections (22). 

The nature of healthcare systems varies widely, from the centrally funded NHS in the UK to the more free-market insurance-based system of the US. In between these two there are also many variations. Additionally, distributed healthcare can be direct to the consumer, bypassing healthcare professionals entirely. This may bring great convenience, choice and potentially health benefit to the consumer but there also some pitfalls. Each country will need to decide how to regulate this growing market.  

We spoke to Giles Sanders, Head of Diagnostics at TTP, about some of the motivations for moving diagnostics closer to the patient. 

“In my view, widespread integration of distributed diagnostic approaches will be key to an effective future healthcare environment. We should note that the concept of distribution should not mean focussing solely on the point of care. As we have touched on in this document, it can encompass a range – from bringing complex tests such as sequencing away from core central facilities to smaller hospitals to at-home testing (or sample collection).   

In all cases, distribution of diagnostics would improve health equity and be a step towards enabling access to healthcare and suitable therapy to all. Diagnostics should be a first line of defence and the step in enabling prevention and correct treatment throughout the world, and the cost of missed diagnosis and prevention opportunities far outweighs any direct diagnostic cost. Beyond high-income nations, it is estimated by the WHO that less than 1% of primary clinics in LMICs have basic diagnostic capabilities – the human cost is unimaginable. 

In the US, the largest healthcare market, the push towards distributed diagnostics will be driven by all the usual considerations, such as quicker results, better patient management and improved health equity and access for all. However, those ordering the tests in healthcare settings also benefit from an increased level of reimbursement compared to sending samples away to central lab facilities. Therefore, we may see the US leading the way in some aspects of the adoption of distributed diagnostics.  

However, though partly financially motivated, patients benefit from quicker and more convenient diagnostics when they need them (which is currently driving home and OTC diagnostics). The solutions gaining traction in the US market should filter down to other healthcare systems that may have more in-built drag and this will also ultimately benefit patients.   

In the UK, we are starting to see further institutionalised distribution with the creation of NHS diagnostic clinics. Although these are initially focused on diagnostic imaging, IVD cannot be far behind. Additionally, governments (and consumers) are increasingly expecting pharmacies to provide diagnostic results to patients outside of traditional primary care. 

There are a number of core tenets that should drive those looking to develop or adopt further a multi-tiered environment of distributed diagnostics: 

  • Quality – the sensitivity and specificity of the test should be fit for purpose and typically match central lab quality. 
  • Simplicity – suitable for the intended users and location of the test 
  • Cost – unfortunately in current healthcare systems distribution does not mean a different reimbursement – so costs need to be comparable with central labs and lower for full distribution to LMIC economies. 
  • Suitability – not all tests need to be, nor should be, distributed to all locations.   

As we have touched upon in this review, there are key areas where distributed diagnostics will provide a future first line of defence for health systems; this includes against future pandemics, extending the runway against the threat of AMR through better antibiotic stewardship. This may also include support and resilience against diseases brought on by the further geographical reach of disease vectors arising from climate change. 

The Covid-19 pandemic has increased the public’s expectation of speed, simplicity and accessibility of diagnostic tests. This is a fertile environment for tests to be expanded into non-standard locations and also to the home. This is of course a great opportunity for test developers and manufacturers but also a positive step for those who want to access healthcare in a way that suits them best and actively manage their own health. Going forward, it will be crucial to develop the right product for the right setting, offering ease of interpretation to the intended user. Our review shows that this may be the patient in their home, but also other users in a wide range of other settings.  

Looking to the near future, we will also see an unparalleled level of connectivity enabled by 5/6G communications and the proliferation of satellite communications systems. This should bring the ability of complex analysis (be this AI or other) and expert interaction to all.  Hopefully we will see a pragmatic approach to data standards allowing for ready integration with healthcare providers and clear approaches to data ownership. 

Despite past false hope and false promises and despite the current challenges for companies that moved so fast in delivering solutions for COVID, distributed systems will be a key part of the future of diagnostics and healthcare – providing added cost effectiveness for healthcare systems, increased disease resilience through rapid screening and monitoring and better experiences and quicker routes to the right treatment for patients.” 

Conclusion

Distributed diagnostics are becoming established in physician’s offices and other acute care settings, ambulances, pharmacies and community diagnostic centres and, importantly, the patient’s own home. Beyond traditional healthcare settings, there are also opportunities for diagnostic testing in hard-to-reach communities, where testing may be combined with test-and-treat strategies. 

And as diagnostic testing is distributed, the benefits for patients, healthcare efficiencies and wider society are many. The experiences of the key opinion leaders we have spoken to show that this is a vibrant sector full of ambition to make a difference with many possibilities. 

Importantly, recent experiences show that not only are distributed diagnostics non-inferior to central lab testing – for which there is by now ample evidence – but they are increasingly translating into superior patient health outcomes. This will continue to be a major theme in distributed diagnostics in years to come. 

Discussions often focus foremost on metrics flowing from the shorter “time to results”, but there are also many other less readily measured healthcare efficiencies. Improvements to the patient experience similarly include so far underappreciated aspects, such as a reduced need to travel for appointments. Buyers are starting to recognise the wider range of benefits of distributed diagnostics in their purchasing decisions. 

We are confident that, more than ever before, it’s true to say that distributing diagnostics will help shape the future of healthcare. 

References

Elena Boland
Consultant

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