Getting To The Point
Are we on the brink of a new era of Healthcare Diagnostics and Point-of-Care Testing?
It is estimated that 70% of clinical decisions are based on diagnostic tests and with the scientific community constantly developing new tests, designed to provide clinicians and patients, with better information about their condition, this percentage is only likely to increase. The majority of these are run in large centralised clinical pathology labs, where economies of scale and quality of results are paramount. However, many of these tests have potential application in Point-of-Care Testing (POCT) situations, where testing can be most effectively performed in emergency situations, doctor’s offices, pharmacies, workplaces and people’s homes.
POCT is valuable because it can deliver results in situ and in real-time, immediately closing the loop of diagnosis and therapy decisions. This can be important in emergency and critical care settings, such as emergency room or paramedic, where rapid diagnosis is essential. In doctor’s offices, it offers efficiencies for physicians, where patients can be treated in a single appointment, as well as reducing anxiety and improving convenience for patients. POCT technologies also have an important role to play in developing markets, where funding and infrastructure to support the model of large centralised laboratories does not exist.
However, there is often a frustration than many innovative, and potentially valuable tests, are taking too long to get to market or are not getting there at all.
So what are the key factors to consider in successfully bringing a POCT system to market?
Evidence Based:
To gain real traction the test must have proved itself to improve patient outcomes and be justified in hard healthcare economic terms. The path to achieving this evidence is often a long and expensive one, involving clinical trial with devices and test consumables first embodied in production-like form. Carefully considering the pathway to proving the real clinical value of the test should be built into the business plan of the development of any new diagnostic test.
Accuracy & Quality:
To be widely accepted, a diagnostic test must demonstrate accuracy and consistency. Lab-based tests have the advantage of the QC procedures that can be realised in the controlled environment of a large laboratory facility. Tests done in remote locations, outside the controlled environment of the lab, have a tough job of ensuring that they are performed to the equivalent level of accuracy and control as those conducted in the lab.
Usability:
Point-of-Care tests are often undertaken by non-specialised staff and sometimes by patients themselves. Designing a useable product is not only an FDA requirement to ensure safe use but an imperative to allow users to carry out tasks simply and confidently. It’s important to consider not only the usability of the test itself, but all the elements of the system including: sample preparation, quality control procedures and entry of user and patient information.
Workflow:
With different types of users and environmental settings, it’s pivotal to look at workflows. This top level interconnected journey of the patient and Health Care Professional (HCP) needs to be clearly mapped and identified to ensure a seamless integration of any new device into a given system. Considerations should include:
- How long does the HCP spend with the patient?
- Who takes the sample and who performs the testing?
- Does the patient wait whilst the tests are being carried out?
These are all critical elements which could affect uptake and device acceptance.
Economic Case:
The cost per point-of-care test is likely to be significantly higher than a lab test can deliver. The resultant payback on the total cost of care, based on improved outcomes of a POCT system is often hard to prove, but is essential to encourage adoption by healthcare managers and payers.
Despite these challenges to bringing a POCT to market, there is increasing encouragement and incentives for the scientific, clinical, design and business communities to do so.
Firstly, there are important new drivers for POCT, such as the need to tackle antibiotic resistance, much of which has been created by over-prescription of broad spectrum antibiotic drugs. According to the Longitude Prize, a challenge with a prize fund of £10 million, run by Nesta, the UK’s innovation foundation, “Point-of-care test kits will allow more targeted use of antibiotics, and an overall reduction in misdiagnosis and prescription. Effective and accurate point of care tests will form a vital part of the toolkit for stewardship of antibiotics in the future. This will ensure that the antibiotics we have now will be effective for longer and we can continue to control infections during routine and major procedures”. Teams from around the world, seed funded by the Longditude Prize, are currently working on a range of new diagnostic systems for POCT settings.
Secondly, new technologies have enabled the reduction in size and cost of testing. Miniaturisation will allow the “lab” to be deployed on small, portable handheld devices and even on the test consumable itself. The availability of improved connectivity, derived from mobile devices, is key to maintaining connection to the central lab information system (LIS), ensuring maintenance of results management and QC procedures.
Thirdly, the regulatory landscape for POCT is changing with transition towards a new in vitro diagnostic (IVD) directive, providing clearer classifications and one that is more flexible in response to the increasing pace of technological development.
Lastly, and importantly, as healthcare inevitably moves towards a more consumerised model, patient expectations will increasingly drive demand for more immediate and convenient diagnoses of health conditions. Elizabeth Holmes’ ill-fated venture, Theranos, which offered convenient, rapid, fingerstick blood test diagnostics direct to consumers, illustrated the potential of this trend (despite its fall from grace last year) and suggests that new, revolutionary, direct-to-patient, and point-of-care diagnostics tests, will be a key part of the future healthcare landscape.
