Valerie Phillips, healthcare expert at PA Consulting discusses the advancement and benefits of at-home testing
In 2021, a quiet revolution happened in the world of diagnostics. Billions of COVID 19 tests were undertaken independently across the globe by people of all ages, in their homes. For the first time ever, it was demonstrated on a global scale that lay people can effectively perform independent diagnostic self-tests. Self-testing became the norm. Clinical terms such as “antigen”, “lateral flow”, “time to result” and “infectious levels” became part of everyday life. Along with this came empowerment. Citizens were able to make informed decisions – to leave the house or stay in, to isolate or socialize safely, or to visit an elderly relative. Now that the pandemic era has ended, the question remains whether this global experience in self-testing can be built upon. Can self-testing be used in non-pandemic situations, and outside of infectious disease control, to enable meaningful health outcomes?
What are the key factors which will support self-testing in the future?
Prior to COVID, diagnostics were very much viewed as being firmly in the domain of health care professionals, with expert training required to undertake professional testing. Because professional testing capacity could not be ramped up to cater for the demand of COVID testing, self-testing at mass scale was developed and over a period of time, lateral flow devices evolved to provide enhanced usability for lay users. Buffer vials were pre-aliquoted, test packs became smaller for home use, components required for one test were assembled together, visual aids were printed on instructions for use, and digital readers were developed to improve the accuracy of results reading and reporting. This product development evolution demonstrates that there is potential for other diagnostic products to be designed around lay persons to enhance usability, provide clear guidance, and reduce human error in sample taking, the operation of tests and reading of results. User-centric design will be a key driving factor in enabling lay person self-testing across multiple indications outside of pandemic conditions.
Robust clinical evidence
Historically, not many diagnostic tests gained regulatory approval for use as self-tests, given the lack of clinical and usability evidence. Regulators had not seen many self-tests, designed with the lay user in mind from the outset, and the supporting clinical and usability studies to evidence that self-testing can be adequately undertaken by a range of users of various ages and demographic profiles. Designing and undertaking self-test studies which meet and surpass regulatory requirements will be a key factor in providing robust evidence and reducing any regulatory and clinical concerns about potential end user risk. This is a key factor in creating trust amongst clinicians and acceptance into clinical pathways.
Segmented product portfolio approach
Given the wide range of health conditions and user needs, future self-tests will need to recognise various requirements across disease pathways and be offered accordingly.
This will require a diversified portfolio approach with self-tests being offered for a range of conditions, incorporating a variety of appropriate sampling techniques and chemistries. For example, respiratory diseases (nasal sampling – lateral flow), kidney diseases (urine sampling – dip stick and/or lateral flow), and biomarker testing (blood sampling – finger pinprick testing). Moreover, pre COVID, the most widely used sampling techniques for self-testing were blood pinpricks and urine. However, there is now mass acceptance of nasal and throat sampling which has resulted in public acceptance of and engagement in additional sampling techniques. This has opened the market to wider use cases ranging from acute infection diagnosis to chronic condition care to recognizing potential health concerns and supporting preventive care.
Meaningful actionable results
The uptake and adoption of self-testing will depend very much on the healthcare system’s ability to recognise, accept and incorporate self-reported results into care pathways, leading to clinical action and meaningful clinical outcomes. Self-reported results could enable targeted population health management at scale, at risk monitoring, cohort triage, primary care access levers, the enablement of self-care through targeted patient information and qualified routes to HCP in-person appointments, as required. This is an area which is largely underdeveloped but has enormous potential to enable new care models and triaged access to in-person clinical interventions, supported by data and evidence. The desire and drive from the health system to incorporate self-reported results into established care pathways will be a key determining factor for the extent to which self-testing will be adopted at scale.
Affordability and accessibility
There is no doubt that self-testing is convenient and enables patient empowerment, and there are currently many self-testing products on offer to those who can afford them. However, unless self-testing products are affordable and offered at scale across the system to ensure equal access, then the take-up may remain in the hands of the few who can afford it. Affordable, accessible self-testing has the potential to remove health inequalities at scale as it can overcome access barriers, including location, depravation and regional/local capacity constraints. To realise this will require a fresh perspective, a new approach to health provision and a willingness across the healthcare landscape to change the way healthcare is accessed and delivered. We are likely to see several markets emerge in parallel; affordable retail self-pay products for self-care, wellness and prevention. Government-funded products for vulnerable sections of the population to enable timely and accurate intervention; and insurer provided offerings to enable self-care and a detailed patient cohort view, underpinned by data.
So, what is the outlook for self-testing as we enter the post-pandemic era?
To effectively extend self-testing into new disease areas will require collaboration from a whole host of players across the eco-system. Innovators will need to design user-centric tests which are intuitive and reduce potential human errors. Test manufacturers will need to consult with regulators and take on board their input to design and undertake clinical and usability studies which provide the evidence basis required. Crucially, health systems will need to incorporate self-testing into clinical pathways and enable results integration and actionability. Tests will need to be affordable and made available to a wide range of users, whether this be via the high street and online self-pay, insurers or Government-provided schemes.
What we have learned from COVID is that lay users are eager and ready to engage. Behaviours have been modified at scale. There is appetite amongst the public to self-test and self-manage. Crucially, health systems now appear eager to incorporate self-testing, given the pressure on health systems to provide care with fewer resources. To bring about change at scale across multiple conditions will require extensive collaboration between multiple parties. There is growing consensus amongst these parties as to the potential upsides and improved patient outcomes.