The current state of in vitro diagnostics is no longer fit for purpose. Inadequate procedures mean that critical insights are often missed, while expenditure statistics on both sides of the Atlantic reveal lagging levels of investment. This situation can’t be allowed to continue. In my view, it’s time to seize the potential of emerging techniques and technologies to deliver improvements across this vital area of clinical testing.

Want to discuss further

Opportunities certainly exist to drive change and spark a move towards earlier disease detection and prevention. Here at CC, we work day-to-day on such challenges. Often, the team is collaborating with start-ups which are developing new clinical diagnostics. Specific examples include lateral flow tests that give instant answers with polymerase chain reaction (PCR) sensitivity to determine disease status. The new kinds of low-cost tests we’re developing will be accessible in the West and developing nations alike.

COVID-19 was a wake-up call to the health industry, highlighting the need for accurate at-home testing, and we were proud to contribute to the fundamental technologies behind the first FDA-approved over-the-counter COVID-19 diagnostic test in the United States. Sean Parsons, founder and CEO of our pioneering client Ellume, was kind enough to describe the CC team as ‘geniuses in the truest sense’ as our case study on the project reveals.

As far as I’m concerned, the urgency of the last couple of years shouldn’t be allowed to recede – broad areas of in vitro diagnostics (IVDs) remain ripe for innovation. Broadly, current diagnostics are often limited by only being able to offer a snapshot of a single parameter frozen in time. Frequently, this is a single piece of data which governs important, and in some cases life-saving, decisions. Of course, looking at only a single data point, which might direct further monitoring, makes it likely that you are missing critical insights.

Discrepancy between value and investment

Within the UK National Health Service, in vitro diagnostics informs 70% of all clinical decisions taken – yet only 1% of NHS expenditure will be invested in diagnostic testing. The story in the US is only marginally better. With just 2% of total healthcare spending, IVDs influence more than 66% of clinical decision making. This demonstrates the clear discrepancy between the value placed on diagnostics, and our investment in them.

A 2015 National Academy of Medicine report was damming on the issue. It concluded: “The delivery of healthcare has proceeded for decades with a blind spot: diagnostic errors – inaccurate or delayed diagnoses – persist throughout all settings of care and continue to harm an unacceptable number of patients.” Arguably diagnostics are not fully appreciated, or perhaps adequately invested in. Certainly, concerns persist around the accuracy of IVDs.

The National Academy of Medicine reported that at least 5% of US outpatients experience a diagnostic error. Six to 17% of adverse events in hospitals result from diagnostic errors, which contribute to 10% of all patient deaths. This clearly represents a significant challenge we must face now. But underinvestment will not improve the status quo, and if COVID-19 taught us anything, it is that IVD testing is critical in the control and management of pandemics. Beyond that, IVDs are essential to the evolution of our healthcare system – and must be improved in several ways.

These improvements should include:
• Accessibility democratization – testing for all which should include more point of care and testing at home
• Reduced time to result – improved efficiencies from getting a diagnosis to the clinician quicker and even starting the appropriate treatment when the patient is already in a clinical setting
• Increased accuracy and reduced false positives and negatives
• Reduced costs and the removal of barriers to use

In the shorter term, more robust and accurate IVDs will have a significant impact in the healthcare system. Early detection fits with the personalized medicine approach – a tailored support regime which accounts for genetic variations in patients, knowing which treatments work and which don’t. This has the goal of preventing the onset of specific diseases and offering the best treatments where there isn’t a treatment to stop the disease. However, the longer-term goal has to be moving the burden away from treatment towards early detection and prevention.

Continuous patient monitoring

Such a seismic shift in the role of diagnostics in the healthcare system will have significant economic benefits and positively impact patient outcomes. But it will require the need to monitor patients for longer periods, potentially moving to continuous monitoring for everyone. For successful continuous monitoring, diagnostics needs to rely on non-invasive detection that can seamlessly co-exist with the patient’s lifestyle without being intrusive. Technological advances – combining the diagnostic depth and coverage of currently complex techniques like molecular diagnostics with easily accessible samples such as sweat and saliva with simple at home tests – could provide such a route.

In any case, the immediate challenges would be to develop molecular diagnostics which are more sensitive, where the technology can be democratized and doesn’t need expensive hardware, and where the data output is manageable. Perhaps it would be directly uploaded to the cloud and advanced AI can detect changes or abnormalities quickly, without the need for human intervention which will be critical with the floodgates opening on all of this data generation.

Moving access from clinical settings to home use and point of care is key. Here, CC is making strides to make this much more accessible. Digitization means tests can be taken at home, quickly, when needed, and the results can be sent to clinicians immediately to make a quick diagnosis and ensure prompt, appropriate medical treatment. Wearables that offer robust data over a longer time period are aiding the transition from the single snapshot, single timepoint analysis.

As I hope I’ve made clear, my colleagues and I are constantly pushing the boundaries of science and engineering. Often, we are working on projects that we are not able to talk openly about. If you have ambitions in the space – or are interested in any of the topics I’ve raised – please do talk to us about your challenges. We’d be delighted to share our thoughts.
 

Author
Andrew Goulter
Associate Director Medical Technology Division

Andrew has 20 years’ experience in the Life Sciences industry, including working in the biotech industry in drug development and product development and realisation companies developing scientific instrumentation and medical devices.