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POCT The Power to Disrupt – UK IVD Landscape, Opportunities and Challenges

By August 25, 2023No Comments

At the Point of Care: The Power to Disrupt, London 2023 conference held at the Royal College of Pathologists and hosted by Thornhill Healthcare Events (Tony Cambridge); BIVDA delivered a thought-provoking presentation on the opportunities and challenges in the UK facing POCT testing and its potential to deliver dramatic and positive changes in care pathways for patients and service delivery partners across the NHS.

With BIVDA representing at least 97% of IVD companies active in the UK, BIVDA is ideally placed to provide a comprehensive and accurate reflection of the landscape and to be able to examine the opportunities and challenges across the sector with the necessary understanding and experience to affect change.

The breadth of the membership, from global multi-nationals to university spin-outs, enables policy and decision makers to access the best technologies and utilise the most experience to deliver their policy aims.

The pandemic brought point of care testing (POCT) into the spotlight and increased the public awareness that diagnostic tests could be available to test, diagnose and potentially guide treatment for a disease or condition. The UK diagnostics industry had to move quickly to respond to the testing strategies proposed by the UK government through the pandemic whilst also maintaining the provision of tests for wider services: this was an extremely challenging time for the industry with the system turned upside down but brought diagnostics and particularly IVDs arguably on to a level playing field with therapeutics and drugs and where IVDs belong.

Emerging from the pandemic, there is a clear and obvious change in the recognition of the role that IVDs play in diagnosing and treating the population and that POCT is a huge opportunity for early diagnosis, targeted treatment, and chronic disease management.

Now, the potential is being looked at within the system in more detail and the use of POCT is being considered across a much wider number of conditions and service delivery settings, including respiratory, heart failure, stoke, frailty and diabetes, emergency care and more.

The environment for advancing POCT into wider use has spectacularly changed almost beyond recognition, however this is where the challenges appear.

There is an obvious and glaring gap in the range of evidence required for the system to adopt and implement wide scale POCT testing. This isn’t limited to service delivery either, this is across the IVD industry in terms of the market size, spend, scope and opportunity. The UK market audit gives a figure of around £300m, but certainly with a significant amount missing due to non-participants which is particularly high in POCT. Even BIVDA’s member data has missing information with gaps in segmentation information such as number of employees, R&D investment, manufacturing information and commercial data. The frustrating thing about this is that collectively we have it and this should not be a complicated activity to obtain. The benefits far outweigh the effort.

NHS England has been trying to implement ARI hubs for what feels like forever, and they cannot get to a point where they can even develop guidance for service delivery settings to adopt. For ARIs, the questions that NHSE want to answer are:

  • Which patient groups to target.
  • Does testing change diagnostic or management outcomes.
  • Antibiotic prescription patterns with POCT.
  • Populations where POCT provides greatest impact.
  • How a combined respiratory viral and CRP testing model would impact outcomes.
  • Including additional healthcare appointments, ED attendance, Mortality.
  • Qualitative data to understand clinicians and patients views on POCT.
  • Patient acceptability and onward health seeking behaviours.
  • Qualitative data understand enablers and obstacles for broader uptake of POCT.
  • Health economic evaluation.

The requirement for more evidence isn’t just applicable to ARI hub implementation. Industry has known this for years and have not done enough to address it, unlike the pharma industry.  Of course, pharma is more evidence based and perceived to be better resourced (not that we know that, due to lack of evidence).

It’s also fair to acknowledge that until now, the demand signalling from the NHS has been patchy at best, so it has been difficult to work with them to generate the evidence, how evidence is recognised has been a challenge, the system structure and silos are complex and lack of mandate from the centre doesn’t help. But, to be honest, industry needs to step up and move away from features and benefits sales to solution and outcome based sales. It’s in the patients’ interest, the clinical workforce’s interest, UK PLC’s interest and, at a granular level, it’s in the innovators’, manufacturers’, distributors’ and BIVDA’s interest.

The signals are coming now: the un-met needs are identified, the innovation pathways are refined (still not great admittedly) but who is responsible for generating the evidence that POCT testing can deliver cost savings and better clinical outcomes for the NHS?

Industry can generate the evidence required to prove beyond any doubt that POCT delivers a faster time to results, a faster diagnosis for patients, the convenience that the public, patients and clinicians have become aware of and an overall better landscape in healthcare with key policy objectives thrown in for good measure such as antibiotic stewardship, reduced pressure on acute care, health equality for communities and reduction in overall costs across the system.

BIVDA has working groups pulling expertise, knowledge and experience from across the sector so these working groups are going to do some work to look at the challenges, the evidence required to overcome those challenges and provide the answer to the questions coming from the centre so that we can get on with the necessary advocacy with evidence to drive the changes needed to grasp those opportunities that we identified as far back as 2009.

This work will be through our Near Patient Testing Working party and our Infectious Diseases working party.  Get your names onto those lists and let the work begin.

To join either of these working groups, please email  NPT or IDWP join request

Ben Kemp