The rise in self-testing and the role of GPs

In 1971 a discreet revolution began in Montreal, playing out on the shelves of the city’s pharmacies.

There, a pregnancy home-testing kit named Predictor – invented by US product designer Margaret Crane – was first sold for $5.50, promising results within two hours.
 
With the tagline ‘Every woman has the right to know whether she is pregnant’, it is now widely recognised as the first reliable home-testing pregnancy kit.

It proved a milestone for accessible health technology. By the end of the 1980s, home pregnancy tests were a blockbuster product, with one study indicating a third of American women had used them.
 
But any signs of a wider home-testing revolution burned surprisingly slowly for many years.
 
There have been notable exceptions, including for people living with diabetes who have used blood-glucose testing for insulin management for decades.
 
In the mid-2000s, some believed a new era of home-testing was dawning in full when a Silicon Valley start-up called Theranos promised to ‘democratise healthcare’. Founders claimed its finger-prick test bypassed the need for traditional blood tests  and offered assessments for conditions from Lyme Disease to vitamin deficiencies to sexually transmitted infections.
 
But investors in a company that was at one stage valued at around $9 billion were ultimately left empty handed after the technology was shown to be ‘nothing more than a mirage,’ as one judge recently said. The founder was jailed in 2023.
 
Accuracy will always be key and was cited prominently by the Therapeutic Goods Administration (TGA) in a 2019 consultation paper looking at in vitro diagnostic (IVD) medical devices for home testing.  Flagging the risks of false negatives and false positives, the regulator also highlighted the importance of ease-of-use and interpretation when non-clinical people conduct their own tests.
 
The role of the COVID-19 pandemic
Shortly after that paper was released, change was turbo-charged with the onset of COVID-19. With regulations tweaked, rapid antigen tests were soon piling up in households around the country.
 
It was a significant shift. Self-tests for serious disease had been banned since 2010, with an exception made for HIV self-tests in 2014.
 
In a short time, the path was cleared for IVDs assessing diseases such as flu and gonorrhoea, as well as COVID-19 – along with the range of existing self-tests for cholesterol, iron or vitamin deficiencies. Home-testing for non-infectious conditions such as diabetes, kidney and cardiovascular disease was also officially allowed.
 
For Professor Mark Morgan, Chair of RACGP Expert Committee – Quality Care, the changes are a mixed blessing for GPs.
 
‘On the positive side, the more people who are engaged with their health, the more opportunities arise for lifestyle and pharmaceutical interventions,’ he told newsGP.
 
‘On the negative side, information for its own sake without context is often low value. There can be lots of anxiety provoked by out-of-range tests.
 
‘There can be delayed diagnosis or false reassurance from tests that are low quality. Some of the testing is medically unnecessary but commercial interests will drive testing anyway.
 
‘We are seeing this with the plethora of online and drop-in blood testing available privately.’
 
With the use of health devices including smart watches and smartphone apps also growing exponentially, Professor Morgan recognises the phenomenon of personalised testing and monitoring is not going away.  
 
Like many, he believes the market is likely to expand much further as health-conscious individuals seek more data and instantaneous feedback. He also sees health demographics playing a part.
 
‘The increasing proportion of us with chronic conditions that need to be monitored will also drive development and sales,’ he said.
 
A changing role for GPs?
For Professor Morgan, the changes are already causing a shift in traditional healthcare practice.
 
‘We teach medical students to only do a test where the result will change management,’ he said.
 
‘Self-testing moves the dynamic towards managing the fall-out from a lot of self-directed testing.
 
‘The GP role will increasingly be that of health coach and interpreter of results, answering questions like “what does this result mean for me?”’
 
Professor Morgan notes that evidence and clinical guidelines have been carefully synthesised in the RACGP Red Book to pinpoint screening with more benefits than harms.
 
‘Widespread home testing becomes a de facto screening program with all the potential harms of over-diagnosis and over-treatment,’ he said.
 
Alongside commercial entities, governments too have taken advantage of changing technology and attitudes to introduce accessible screening at home.
 
The population-wide screening program for bowel cancer, with kits sent to home addresses based on age criteria, has been up and running since 2006. Meanwhile, a self-collection option for cervical cancer screening was introduced in 2022 and broadened since.
 
Such programs are only as good as the scale of their take-up, as GP Associate Professor Joel Rhee says.
 
As Chair of RACGP Specific Interests Cancer and Palliative Care, he notes the participation rate for the bowel cancer program stands at around 40%.
 
‘There is still a lot of work to be done in ensuring that a greater proportion of people are using and returning the test kits,’ he told newsGP.
 
‘Another challenge is ensuring that everyone in the community is accessing and benefiting from screening, including Aboriginal and Torres Strait Islander people, people from culturally and linguistically diverse backgrounds, and people with lower socioeconomic status.’
 
Echoing Professor Morgan, Associate Professor Rhee expects more change ahead but is not clear what form this will take.
 
‘There’s significant potential for point-of-care testing for cancer – both in screening and as part of a diagnostic evaluation, but it is early days, and more research is required before they are integrated into routine clinical care,’ he said.
 
Importantly, for those government-funded programs, a GP or another health professional is guaranteed to be on hand to help oversee the process, including sharing results.
 
When those safeguards are loosened, or absent altogether, Professor Morgan has substantial concerns.
 
‘Home testing for serious conditions will happen without the appropriate pre-test counselling and nuanced “breaking bad news” consultation,’ he said.
 
‘I can only imagine how distressing it would be to get a bad result from doing a novel cancer marker test at home.’
 
The potential of wider home-testing to fragment care and undermine general practice’s holistic approach towards health is another worry.
 
It was an issue voiced by the Chair of RACGP Specific Interests Sexual Health Medicine Dr Sara Whitburn last year, after the TGA approved Australia’s first self-test kit for chlamydia and gonorrhoea.  
 
While welcoming the increased accessibility it offered, she also noted the test was no replacement for a GP taking a complete history, or an examination to diagnose and treat underlying causes.
 
‘As a screening test, it is recommended that individuals consult a healthcare professional for a repeat PCR test to confirm a positive diagnosis,’ she told newsGP when the test was announced.
 
‘This reliance on follow-up testing may inadvertently delay diagnosis and treatment, especially if individuals do not seek a health assessment.’
 
Clinical impact
Regulation remains a fluid area, with a new TGA consultation on IVDs now out. It expects further changes will ‘shorten the time taken for products to come into the Australian market and reduce regulatory burden’ as well as ‘reduce public health and safety risks, and increase consumer confidence’.
 
In short, more confirmation that the proliferation of self-testing choice is unlikely to slow down any time soon – a far cry from pharmacy shelves in Montreal in 1971.
 
But while the market changes are supported by industry and consumer groups, one group of New South Wales public health researchers recently dug a little deeper into the clinical impact.
 
In a study published in the British Medical Journal, they considered 484 online direct-to-consumer tests – explicitly excluding home collection kits for bowel cancer, tests triggered by pandemic responses, point-of-care testing or self-monitoring tests for patients managing conditions such as diabetes.
 
The home tests they analysed are most likely to be ordered by healthy consumers, they concluded – and are mostly of limited benefit, if any at all.
 
‘Direct-to-consumer tests might seem like a good idea, but in most cases, you’d be better off letting sleeping dogs lie if you feel well or going to your GP if you have concerns,’ they wrote.
 
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COVID-19 HIV self-testing