At-home medical testing has come a long way since the first over-the-counter pregnancy tests went on sale more than 35 years ago.
Today, home testing kits have evolved, and their applications expanded. There are tests available to assist with diagnosis of a wide range of conditions, from sexually transmitted infections and stomach ulcers to Alzheimer’s disease and even cancer. Patients with long-term medical complaints can accurately monitor their conditions using home testing kits, such as diabetics checking their blood glucose levels, while people with an interest in their ancestry can buy over-the-counter genetic testing kits.
Even pregnancy test technology, based on the simple lateral flow immunoassay, has advanced from simple line-based yes/no systems to digital platforms that can accurately determine how many weeks pregnant the user is and is now coupled with fertility monitoring for those wanting to know the ideal time to conceive.
The market for home diagnostics is large and growing fast. A 2017 report said ~30% of revenue ($1.4Bn) of this market is based on lateral flow cassette devices, which is expected to more than double in revenue the next couple of years, with the overall market expected to grow from $4.78 billion US in 2017 to $6.53 billion US by 2025.
One of the main selling points of the early home pregnancy test kits was that they would allow women to test for pregnancy in the privacy of their own homes without the need to consult their doctor.
While convenience and privacy are still important factors that drive the home diagnostics market, equally important is the accuracy and speed of obtaining a result that today’s tests provide. People are growing more aware of the importance of their own health and wellbeing and are increasingly expecting and demanding more personalised healthcare.
With the growing financial and resource pressures on public health systems around the world, innovative new technology is allowing patients to take their healthcare into their own hands. In countries where healthcare is expensive or otherwise restricted, home testing can provide a more easily accessible and affordable option for people to obtain a diagnosis quickly and efficiently.
Another benefit of the advance in home testing technology is the data it will generate. I have written on this website before about the growing value of data in healthcare. Now many scientists and researchers are actively working with the companies that produce home medical tests and using the data they collect to advance medical science.
I firmly believe that home diagnostic test technology is transforming healthcare, putting power in the hands of patients, saving them valuable time and money and easing the burden on stretched public health services.
One day I believe home testing will advance to the point where it will replace a visit to a doctor for a large number of things. Just as the home pregnancy test is now the recommended first step of the pregnancy journey in most advanced health systems, so will other tests become the first step towards diagnosing and treating a whole host of conditions, from allergies to HIV, heart disease and cancer.
Though home tests are becoming more accurate and capable all the time, we are not yet at a level where they are routinely used or even recommended by healthcare professionals. There are many reasons for this, such as regulatory barriers, but one of the biggest issues that I feel must be overcome for the full potential of this technology to be realised is public perception and understanding.
I was struck by a recent segment on the UK consumer journalism programme Watchdog that claimed to investigate the efficacy of home health testing products. The “investigation”, which was prompted by a celebrity doctor’s concern over the use of home tests, looked at the way certain tests were marketed and sold by some UK pharmacies. While some of these practices admittedly may need tightening up, the segment ultimately served only to validate this doctor’s preconceived opinions of home tests and delivered an overwhelmingly negative message about the home testing market.
A more balanced conclusion can be found in this 2018 report by the British Journal of General Practice, which states self-testing can be “empowering” to patients and “has the potential to improve uptake and patient engagement”, while warning that “rigorous” regulatory systems are needed and “high-quality comprehensible information” about the performance of tests must be made available to clinicians and the public. I agree with this conclusion.
I am also encouraged by the conclusions of this 2014 report into home testing, which reviewed existing literature on the unassisted use of home tests involving self-collection and testing of biological samples by untrained users to predict what could be expected from the then recently-approved-for-use rapid home test to diagnose for HIV.
It said: “The studies reviewed showed that most participants could properly perform home tests, obtain accurate results, and interpret them – yielding high correlations with laboratory and health-professional performed tests.”
I genuinely believe home testing can bring about a positive revolution in healthcare, and that it has the potential to negate the need for clinical intervention in a large number of circumstances. I know that to bring about this change will take a great deal of effort from all sides, and that the opinions and expertise of test manufacturers, doctors, regulatory bodies and patients all need to be taken into account. But if we are sincere about wanting to empower patients and ease the burdens on our health systems, it is an effort we must all make.
Darren Rowles is CEO and president of Sona Nanotech, a life sciences company based in Nova Scotia, Canada. He has 15 years of experience in product manufacture and development in the area of gold nanoparticles and lateral flow diagnostics.