Diagnostics: areas of growth, change, and wider interest that could transform the industry
By Dr Giles Sanders
At a recent “crystal ball” event, I was asked what I see as the top ten areas of growth in diagnostics in the next five years. I don’t have a crystal ball – alas! – nor did the other panellists. But the event prompted me to think about areas of important change as the industry exits the pandemic rollercoaster in 2023.
At TTP, we work with companies in many areas of diagnostics, so we take a wide view of the industry. But I am keen to hear about any trend you think I’ve missed that could transform diagnostics in years to come. So, in no strict order, I am sharing some of my top areas of growth, change, and wider interest in diagnostics.
Diagnostics for neuro-diseases and damage
In the Western world, we are increasingly suffering from diseases of aging. Many companies are working on biomarkers for neurodegenerative conditions, for example Quanterix on NF-L. Interestingly, sequencing has also been demonstrated to provide information and stratification in neurological disease – for example epigenetic markers to distinguish between delirium and dementia.
A French company called ALCEDIAG is developing RNA sequencing approaches to distinguish bipolar disorder and depression, which can have an impact on clinical management. Related, RNA markers in saliva for concussion, a common sports-related injury, have been demonstrated to be clinically relevant.
Diseases of obesity and diabetes monitoring
Another emerging clinical need are diseases of obesity, like non-alcoholic fatty liver disease (NAFLD) or non-alcoholic steatohepatitis (NASH). This has been an area of interest in the pharmaceutical industry for a while – and not without challenges in terms of moving candidates through the pipeline. As some therapies start to appear on the market, simple tools for diagnosis and stratification will be required.
Diabetes monitoring has been a mainstay of the biosensing and diagnostics industry for some time, but the last decade has seen a huge shift in the world of glucose measurement – especially in the US and Europe, from glucose strips to continuous glucose monitoring for more patients. I think this area will continue to grow. Abbot and Dexcom are leading this in the Western world, but many other players are looking to lower cost solutions whilst maintaining quality.
Distribution of diagnostics and more distributed immunoassays
Then there is the distribution of diagnostics. Following the massive acceleration of where diagnostic measurements are taken with Covid-19, I expect we will continue to see increased use of molecular and other diagnostics outside of centralised labs, at points of care, or at least near patients. Delivering central lab quality results – at or near patients – with a wide menu will be a driver in maintaining momentum in this area.
Surprising as it may sound after Covid-19, immunoassays will continue to move to the point of care. Lateral flow tests have existed for thirty years, but immunoassays can be digitised and become semi-quantitative. This area will continue to grow, in concert with the growth of laboratory information management systems (LIMS) and digitisation of data as well as measurement. We will see further extended menus of point-of-care platforms, be that ELISA or other approaches.
Distributed blood and sample collection (and analysis)
We are also starting to see new ways of collecting blood by the end-user or patient without the need for a phlebotomist. In the US, companies like Tasso and Seventh Sense, which is now Yourbio, and Loop Medical in Switzerland have raised funding. To complement this trend, companies like Babson Diagnostics are looking to offer high-quality blood analysis, for example at the pharmacy counter from distributed sampling.
The increasing complexity of tests performed on distributed blood and urine samples will raise interesting questions about sample stabilisation to preserve RNA, cells as well as tumour and microbial cells.
Cell-free nucleic acid sequencing
Cell-free nucleic acid sequencing in all its guises will grow. In addition to well-known companies like Grail with the Galleri test for early cancer detection, a host of companies like Invivoscribe and Guardant are offering minimal residual disease (MRD) monitoring and developing other cancer prognostics as well as diagnostics. Companies like Karius are looking at liquid biopsy for sepsis detection, again using sequencing.
We will definitely see improvements in tissue diagnostics, which I see is a growth and consolidation area. We have the benefit of new dyes, AI in image analysis, and also new biomarkers coming from the spatial biology field, which will find its way into the clinic in the next five to ten years.
High-sensitivity protein measurement
High-sensitivity protein measurement enabled by companies like Quanterix – but also the likes of Olink and SomaLogic, who are enabling either sequencing-based or PCR-based approaches to measuring low concentrations of proteins – is worth keeping an eye on.
Sequencing in the clinic
In this industry, we have long speculated how sequencing will find its way into the clinic. As the industry is seeing substantial change, Nanopore sequencing is in a pole position to do so in the next five years. In the UK, their technology had a major impact in Covid testing. Compared to other methods, this technology offers better read lengths, at a lower cost per instrument and a far smaller bench footprint. This lends itself to more distributed deployment than other platforms.
We have all witnessed the rapid emergence of consumer sensors, for example, smartwatches that not only measure heart rate but that can also record an ECG. Combined with advanced data analysis and machine learning, these sensors can provide at least quasi-diagnostic information in the absence of diagnostic devices. At the same time, with 5G we are seeing faster data transfer, so we can envisage increasing numbers of non-traditional diagnostic devices (be this continuous sensing of heart rate, gait, motion, imaging, auditory behavior, etc.) that offload data analysis to the cloud – to allow rapid detailed computer analysis elsewhere with near real-time pseudo-diagnostic results being fed back.
Rapid antibiotic susceptibility testing
Finally, rapid antibiotic susceptibility testing is now a real worldwide need. We are approaching a cliff edge, and diagnostics that help us give people the right drug at the right time, instead of broad-spectrum antibiotics, will push that cliff edge out by a welcome few years.
Giles Sanders is Head of In Vitro Diagnostics at TTP. From integrating complex processes into easy-to-use and low-cost disposables to developing complementary technologies, his team of world-leading scientists and engineers delivers the diagnostics solutions of the future today.
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If there is a diagnostics challenge you would like to discuss, please reach out to Giles. You can also find more information on our diagnostics page.