The updated case for distributed diagnostics

Whether it’s in the patient’s home, the ambulance, the pharmacy, or the physician’s office, there are so many reasons for distributed diagnostic testing and so many testing locations beyond the traditional central diagnostics lab. 

We discuss some of the latest evidence and the insights of key opinion leaders in order to better demonstrate how distributed diagnostics capable of delivering lab-quality results can create value for patients, healthcare systems, and wider society.  

In this first part of our series, we look at the range of motivations and locations. 

There are so many reasons for distributed diagnostic testing and many testing locations beyond the traditional central diagnostics lab. And the evidence of superior outcomes – using metrics such as cost, testing uptake, mortality and morbidity – is accumulating. 

Our evidence review and interviews with key opinion leaders, found in this series, show that products and technologies that can offer central-lab quality testing but faster results and ease of interpretation bring real gains in terms of patient benefit, healthcare efficiencies and wider societal returns. 

An important lesson from Covid-19 and beyond is that the value of distributed diagnostics doesn’t always derive from moving the testing literally to the point of care. In a variety of ways, distributed diagnostics create value whenever they are moved closer to the patient or test recipient, be this anything from the home or to a smaller hospital. 

In a recent market update, Roche, a global healthcare company, affirmed their intention to “invest to become a leader in decentralized testing” in the home, pharmacy, physician’s office and emergency room while aiming for central-lab quality. At TTP, we strongly agree that this is the right direction for patients, clinicians and businesses. 

Distributing diagnostics: many motivations

There are a number of key reasons and motivations for distributing diagnostics. Many of these are noted below.  The mix of reasons are broad in scope and include patient benefits, healthcare economic benefits and societal gains. 

Motivations for distributing diagnostics

Reduced patient travel distance

Whether they live in a city or rural location, patients will benefit by saving money, time and the inconvenience associated with travel to a hospital. This also impacts the carbon footprint associated with healthcare. This is particularly the case for rural locations in countries such as the U.S.A. where a patient may travel hundreds of miles to a major hospital. 

Improved quality of life

Distributing diagnostics will enhance and extend patients’ ability to enjoy their normal life activities, in particular in their home, by staying better connected to loved ones, and continuing to pursue their goals, hopes and aspirations. 

Greater ownership for patients

Diagnosing and treating a medical condition often feels as if it is governed by doctors and medical procedure. Increasing the locations and tests available outside of traditional medical settings gives patients more choice and increases their ownership of the process. Key to the future of distributed healthcare will also be data ownership. 

Improved patient reassurance

Distributed diagnostics eliminate delays due to sample transport and results transmission, reducing patients’ anxiety as they wait for test outcomes. Quick feedback also allows for timely medical decisions, enhancing patient confidence in their care plan and the effectiveness of their treatment.  In the post-pandemic era, patients expect diagnostic results, even for complex diseases, in a rapid, near-immediate timescale.  

Faster time to treatment

Distributed diagnostics often deliver immediate or fast results. This rapid turnaround minimises delays in starting necessary treatments, improving patient outcomes and streamlining the care process.

Wider ability to monitor treatment progress

Distributed diagnostics provide immediate or faster results more proximate to the patient, which facilitates more frequent and convenient monitoring of patients’ conditions. This allows healthcare providers to adjust treatments promptly based on current data, ensuring more personalised and effective patient management. 

Disease eradication

Distributed diagnostics can reach patients and populations who would otherwise be unlikely to visit traditional healthcare settings, facilitating the identification and treatment of affected individuals. This timely intervention reduces the spread of pathogens, enhances outbreak control efforts, and supports public health initiatives aimed at eliminating diseases.

Reduced carbon footprint

Distributed diagnostics can reduce the carbon footprint of healthcare by minimising the need for refrigeration and transportation of samples to centralised laboratories, and by reducing the need for patient travel. Better outcomes can also translate into major emissions savings. It is important that those developing the next generation of diagnostics do consider their ecological impact and consider routes to reducing petrochemical derived material use. 

Avoiding drug side effects

Distributed diagnostics enable rapid and accurate identification of the specific illnesses or biomarkers. This precise diagnosis helps to ensure that patients receive the most appropriate medication or dose, reducing the risk of adverse side effects from prescribing medication unnecessarily or incorrectly.

Increased treatment uptake

Through immediate test results, distributed diagnostics allow healthcare providers to discuss and initiate treatment plans with patients during the same visit. This immediacy reduces the likelihood of patients not returning for follow-up appointments, thereby improving adherence to treatment recommendations. 

More treatment pathways for patients

Prompt diagnosis allows for a broader range of treatment options to be considered, personalised and implemented quickly, whether it be medication, lifestyle changes, or referrals to specialists for further evaluation or surgical interventions.  

Improved management of chronic conditions

With aging populations, chronic conditions such as cardiovascular disease, cancer, chronic respiratory diseases and diabetes are on the rise. Distributed diagnostics reduce the hurdles to testing and offer faster results, leading to better adherence, outcomes and more immediate detection of problems. Already, more distributed diagnostic products focus on chronic disease management than initial diagnosis.

Better treatment outcomes

Immediate, accurate diagnostic results enable earlier detection of issues and faster clinical decision-making. This can prevent the progression of diseases, reduce complications, and allow for quicker adjustments to treatment plans, ultimately leading to more effective patient care. 

Enabling precision medicine

Distributed diagnostics provide faster and more frequent insight into biomarkers that were previously the reserve of central-lab testing, as well as new digital biomarkers. This information facilitates the selection of appropriate targeted therapies and personalized interventions. Treatment responses to next-generation drugs can be monitored to avoid side effects and optimise outcomes. 

Increased ability to triage outside of hospital

Access to rapid diagnostic results allows healthcare providers to assess and prioritise patients. Improved triage reduces overcrowding in emergency departments and ensures that individuals receive timely and appropriate care, even in decentralised or resource-limited environments.  In a world where hospitals are under pressure, the ability to move triage to primary care and other locations will be a clear advantage. 

Rapidly enabling the right patient treatment

By providing immediate diagnostic information, distributed diagnostics enable healthcare providers to make accurate and timely treatment decisions. This ensures that patients receive care that is tailored to their needs, leading to improved treatment outcomes and patient satisfaction. 

Reduced hospital admissions

By enabling timely detection of complications and exacerbations and improved management of patients’ conditions in outpatient settings or at the point of care, distributed diagnostics help to avoid the need for hospitalisation and acute care services. 

Reduced sample transport

As results are generated closer to the patient, there less need for sample transport. Not only is the time, the use of healthcare resources and the cost associated with sample transport reduced, but clinical workflows are streamlined and the likelihood of sample degradation or contamination during transit is minimised, improving the accuracy and reliability of test results. Distributed diagnostics also improve the environmental sustainability of healthcare by reducing fuel consumption and carbon emissions associated with transportation logistics. 

Greater biosecurity

Distributed diagnostics reduce the time that potentially infectious individuals spend in proximity to others, for example in the waiting areas of healthcare facilities, thereby lowering the risk of disease transmission. Distributed diagnostics can also enhance biosecurity measures in scenarios where access to centralised laboratories may be limited or impractical.   

Reduced length of hospital stays

Distributed diagnostics enable more timely initiation of treatment before disease progression or complications escalate and without additional confirmatory tests or observation periods, all of which can translate into shorter hospital stays. This not only improves patient satisfaction but also reduces healthcare costs and frees up hospital resources for other patients in need of care.  

Reduced anti-microbial resistance (AMR)

Anti-microbial resistance (AMR) is one of the top global public health threats with estimates from the WHO noting that it may well kill more people than cancer by 2050.  In 2019 alone 1.27M global deaths were recorded as a result of AMR; this number will only rise. Distributed diagnostics to differentiate viral and bacterial infections, detect antimicrobial resistance genes, and for rapid antibiotic susceptibility testing play and important role in antibiotic stewardship. 

Enables ‘test and treat’ strategies

Distributed diagnostics eliminate or reduce the wait for laboratory results to confirm diagnoses, enabling clinicians to make treatment decisions. This is particularly beneficial for infectious diseases, where early initiation of treatment is crucial for preventing disease progression and reducing transmission to others.  

Cost saving

The ability to expedite diagnosis, improve treatment outcomes, and optimise resource utilisation contributes to significant cost savings across healthcare systems.  

Outbreak control

Distributed diagnostics provide rapid and on-site diagnostic capabilities, allowing for faster identification of infectious agents and early containment measures, such as patient isolation and contact tracing. Furthermore, real-time monitoring of epidemiological trends facilitates timely adjustments to control strategies to reduce morbidity and mortality and mitigate the impact on public health systems and communities. 

Improved equity of healthcare funding and access

With the benefit of distributed diagnostics, healthcare requires fewer appointments in distant locations that patients must travel to. This translates into healthcare that is more accessible for all groups, alongside a reduction in the number of people who drop out. On both counts, distributed diagnostics will benefit those who are already marginalised.  

Better HAI control

Distributed diagnostics create a finer and more responsive net for healthcare-associated infection (HAI) surveillance, enabling healthcare providers to promptly implement appropriate infection control measures, such as isolation and targeted antimicrobial therapy, to prevent the spread of infections within healthcare settings. This reduces the risk of healthcare-associated infections, improving patient safety and reducing the burden on healthcare systems. 

Distributing diagnostics: many locations

In addition to the many motivations for distributed diagnostics, there are also a vast array of locations where diagnostics may be delivered. With appropriate technologies, diagnostics (and the associated treatment if appropriate) can be targeted to the place where they will have maximum impact. 

‘Point of care’ is a well-used term in diagnostics, implying a movement from a central lab to hospital wards or physician’s offices. However, this term, although useful, is too limiting. Diagnostics can be delivered in additional locations outside conventional healthcare settings. 

The targeting of diagnostics to the most appropriate location can facilitate healthcare gains in terms of patient benefit, societal benefit and healthcare economics. 

Feasible and foreseeable locations to perform diagnostic tests

Some examples of tests in the locations above are noted below. 

  • Ambulance – troponin assays for chest pain enabling rule out triage and reassurance of low risk patients. 
  • Emergency room – Flu and Covid test to enable movement to dedicated ward. 
  • Airports – temperature screening of passengers for rapid triage 
  • Diagnostics centres – with a suite of POC IVDs helping people stay away from hospital  
  • Operating room – rapid assay of potentially cancerous biopsies to determine next surgical step 
  • Regional hospitals – undertaking low throughput sequencing to enable precision medicine without transport 
  • Dedicated clinics – Sexually Transmitted Disease (STD) clinics providing rapid testing and treatment 
  • Physician’s office – rapid point of care molecular testing to provide infection diagnosis and correct treatment 
  • Care home – managing long term conditions effectively e.g. HbA1c for diabetes control  
  • Pharmacy – pharmacogenetic testing ensuring patients have medication that will work for them 
  • School – testing for infections that have the ability to spread and disrupt schooling 
  • Workplace – drug and alcohol screening for those in dangerous occupations 
  • Health visitor – Tests enabling avoidance of unnecessary hospital trips for disabled and elderly people 

In the next part of the series, we start to review some examples of the impact of distributed diagnostics in detail – looking at anticoagulant monitoring in the home, troponin level testing by paramedics or in the physician’s office, and C reactive protein testing in the physician’s office.

Elena Boland

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