The diagnostics industry has always been a hotbed of innovation, no more so than now almost 25 years into the 21st century. According to a report produced by MeticulousResearch, the global rapid diagnostics market is estimated to be worth $29.4 billion by 2029, fuelled by increases in the prevalence of infectious diseases, an ageing population with associated chronic disease management, improved accessibility of test kits, wider application and direct to consumer sales.
The largest adopter of rapid testing products will be established healthcare providers which has extended to the high street in the form of pharmacies and health and wellbeing services. As the governance around these services improves in line with hospital-based care, this sector is likely to grow exponentially. Community based diagnostic services will continue to expand improving accessibility to all patients and drive health equality for those with medical needs from deprived areas.
Healthcare is coming home. Literally.
Care in the Home
More services are being provided to patients in their own homes through the formation of virtual wards to traditional home clinic visits. Alongside these initiatives, the patient has now become the consumer with the ability to legitimately order home testing kits, or home sampling kits from the couch, or obtain them through direct-to-consumer sales in supermarkets and pharmacies. Patients may also be issued with devices and tests as part of the ongoing management of chronic conditions, with results being entered into apps or transferred to cloud-based services where clinical advice can be accessed. The patient can now take control of their condition and access medical advice around the clock.
At LumiraDx we believe the future of effective healthcare is faster, more convenient, and better connected – our LumiraDx Platform is designed to support effective patient care delivery across all three of these aspects, whether that care is taking place in a primary, secondary, or community-based setting. Our core mission is to transform community-based care and we’re partnering with customers globally, and in the UK NHS, in diagnostic pathway transformation across virtual wards/Hospital@Home, urgent treatment centres, community diagnostic or respiratory hubs and within general practice to help alleviate pressure on secondary care settings. One customer example within a Hospital@Home service utilising our CRP test noted quantifiable benefits in patient safety, improvements to patient experience and a reduction in unnecessary repeat visits and hospital admissions². In secondary care settings, our LumiraDx Platform tests are bringing faster, actionable results closer to the patient to transform patient pathways with reliable results in minutes, rather than lab results within hours. As we grow our test portfolio to deliver on our aim to be able to choose from over 30 tests, that can all be run on the same Platform, we continue to scan the market for point of care diagnostic requirements in order to deliver the future of rapid diagnostics for future-proofed healthcare services globally.
Laura Crouch, Marketing Manager UK and Ireland, LumiraDx
However, there remains a focus on hospital-based care and improving clinical pathways with the aid of rapid diagnostics. To a degree, pathways can be designed around the capabilities of diagnostic solutions, as long as the performance characteristics are adequate for the clinical decisions that need to be made.
‘Point-of-Care Testing (POCT) holds the potential to revolutionise healthcare delivery by seamlessly integrating rapid diagnostics into clinical pathways. This advancement empowers healthcare professionals with timely and accurate information, facilitating swift and informed decision-making. The streamlined diagnostic process not only enhances patient pathways but also significantly elevates the overall patient experience. However, the success of POCT hinges on the readiness of healthcare management to revise hospital protocols and foster unified collaboration in implementing this technology.
As a provider of Point-of-Care solutions, our commitment extends to supporting hospitals prepared for this transformative shift. Our dedicated sales and tech support team is poised to assist in seamless integration, offering consultations on how rapid diagnostics can enhance operational efficiency, reduce costs, and optimise patient management.’
Alastair Manning, Sales Director of QuidelOrtho for UK, Ireland and Benelux
Answering the Clinical Question
Managing patients effectively in the hospital environment is key to realising the benefits that point of care solutions and rapid diagnostics can offer, when used in the right setting by trained individuals. Clinical decisions are required at the time of testing to make them worthwhile. Understanding the blockers that prevent decision making, i.e. lack of availability of other investigations/physiological observations, is important to understand if rapid testing is suitable for that environment and those patients.
Clearly, there is a drive to keep patients out of the hospital setting and access alternative health delivery points such as urgent treatment centres and community diagnostics centres.
As the NHS moves towards a process of prevention and early identification of disease, Rapid POC diagnostic tests are becoming increasingly important for the management of people’s health, especially with the challenges faced within the NHS today.
It is a key role of the commercial diagnostics industry to support, and meet the diagnostic needs of the NHS to provide the best possible service to patients, by improving patient therapy pathways, and this can only be achieved through open dialogue and partnership between the NHS and commercial diagnostic companies, to identify the real needs, then developing or sourcing new advanced and progressive technologies from around the world and delivering these innovative products, to meet the needs of the healthcare institutions.
Since 1994 BHR has been at forefront of providing point-of-care diagnostics to the NHS, carefully chosen to assist in streamlining healthcare delivery, improving patient outcomes, and supporting the NHS in making valuable savings in provision of services, in a growing financially challenging time.
This is highlighted in the BHR Mission Statement: “Providing point of care solutions that meet the needs of a changing NHS”
Amin Belal, Director of Sales, BHR Pharmaceuticals (Part of Biosynex Group)
Effectiveness Through Design
The industry continues to evolve with devices and tests showing improvements in accuracy and imprecision. With some results now being shown to be comparable to laboratory methods, faith in the devices and where they can be deployed is increasing. Changes in methodologies and techniques can be difficult to adopt, especially if the interpretation of the output is significantly different to the established tests. Some point of care solutions have been adopted out of necessity, driven by hefty patient case backlogs, a lack of hospital and community bed capacity, and the need for rapid results to move patients through the system.
Simplicity is the key to successful adoption of rapid diagnostics with user experience a major consideration when selecting the right device, the most appropriate test, in the most effective setting.
At LumiraDx we work to empower healthcare professionals’ clinical decision making by providing the lab-comparable results they need, when they need them. Our point of care LumiraDx Platform is designed for portability and speed – allowing flexibility on which test you need to run, where you can run that test, and delivering actionable results in minutes. The room temperature storage (2 – 30°C) of our Platform test strips provides added convenience whether testing in a fixed location or when using our Platform out and about in the community. Delivering actionable results in minutes within a single patient consultation helps to reduce the number of journeys and appointments for patient follow-up, cutting road travel and subsequently emissions¹. With regard to waste reduction and sustainability, our tests strips, with their microfluidic technology and architecture, are smaller than disposable competitor cartridges, reducing plastic point of care clinical waste.
Laura Crouch, Marketing Manager UK and Ireland, LumiraDx
New Routes to Market
A new pilot scheme is now available to support the development of new transformative technologies for adoption within the National Health Service (NHS). The criteria is very prescriptive and ensures the innovation addresses a significant patient health issue (life-threatening or seriously debilitating), is sustainable and/or cost effective, and demonstrates true innovation leading to healthcare transformation.
‘The Innovative Devices Access Pathway (IDAP) pilot is an initiative to bring new technologies and solutions to the National Health Service (NHS) to help with medical needs that are not currently being met.
The aim of IDAP is to enable and improve patient access to innovative and transformative medical devices by providing an integrated and enhanced regulatory and access pathway to developers. The aim of the pilot is to test the main elements of the pathway and to provide informative learning and feedback that helps to build the future IDAP.
The IDAP is open to UK and international commercial and non-commercial developers with new health technology solutions3.’
GOV.UK
Funding Sources
The IDAP programme does not provide any financial support. It will guide the successful applicants through the regulatory minefield whilst developing the product using something termed a Target Development Profile (TDP) roadmap. Financial support within the industry has traditionally come from grant applications, awards and private investment, besides the reinvestment of profits into research and development.
In the United Kingdom, there has been a recent commitment made by the Prime Minister Rishi Sunak to invest heavily in life sciences and related innovations. A new £100 million fund specifically designed to accelerate the development and application of Artificial Intelligence (AI) in life sciences and healthcare was announced. This sits alongside a £2.5 billion investment over 3 years from Microsoft.
‘This £2.5 billion commitment was confirmed … as the Prime Minister Rishi Sunak unveiled £29.5 billion of investment in our most innovative sectors, including tech, life sciences, renewables, housing and infrastructure at the Global Investment Summit 4.’
www.gov.uk
The full report can be read which indicates a substantial commitment to innovation in life sciences, which is set to be a hotbed of AI developments driven by machine learning and digital algorithms. For such a large investment the outputs are expected to be substantial although accessing these funds is currently unclear.
If financial support is gained within the rapid diagnostics industry we could see a transformed landscape in the coming years.
References
1 Greener NHS » Delivering a ‘Net Zero’ National Health Service (england.nhs.uk)
3 https://www.gov.uk/government/publications/the-innovative-devices-access-pathway-idap
4 https://www.gov.uk/government/news/boost-for-uk-ai-as-microsoft-unveils-25-billion-investment
Tony Cambridge is the Managing Director of Thornhill Healthcare Events and Consultancy, and former Lead Biomedical Scientist in the Pathology Management team of a busy acute care hospital in England. He frequently speaks at national and international healthcare events, and is a key opinion leader for point of care testing. He is also a member…
The company was set up in 2018 by Tony Cambridge MSc. BSc. Lead Biomedical Scientist, who is the managing director. With over 20 years experience in Blood Sciences and more recently Pathology management, Tony set out to provide affordable training opportunities to healthcare organisations through a number of different ways, from small group seminars to…