First in-depth exploration of the direct-to-consumer health test market in Australia.
With hundreds of health tests available online with the click of a mouse, the ability to keep on top of your health has never been easier. However new research from the University of Wollongong (UOW) has found this may not always be a good thing.
In an Australian-first study, a team led by sociologist Dr Patti Shih, from the Australian Centre for Health Engagement Evidence & Values (ACHEEV), has mapped the range and variety of direct-to-consumer (DTC) tests that are available online in Australia to analyse whether they are likely to provide any benefit to the people who use them.
Direct-to-consumer tests are sold commercially without requiring a doctor’s consultation. There are three main types of tests you can buy. Some tests you can complete on your own at home. Some provide kits to take a sample, which you then send off to a lab. A third type is a pathology request form, which you buy and then take to a lab. There are hundreds of DTC tests advertised online.
Since the COVID-19 pandemic, the familiarity with home testing and self-sampling has meant these products have proliferated. However, these types of tests differ from home collection kits that are part of pandemic responses such as COVID-19 rapid antigen tests, or screening programs such as bowel cancer screening, nor are they the same as self-monitoring tests for patients already diagnosed with a condition such as diabetes.
Direct-to-consumer tests are products marketed and used by any consumers who are willing to pay. While this offers a lot of convenience and accessibility to tests, it’s not always clear if consumers are choosing and paying for the correct test they need without the discussion and guidance from doctors.
In fact, the study suggests healthy people make up most of the consumers targeted in this market, and most of the products won’t provide useful, actionable information.
“We identified 484 DTC test products online, ranging from $12.99 to $1947 and found only 10 per cent offered potential clinical utility, that is, they provide useful, meaningful information that is actionable and leads to improvement in the consumer’s health outcomes” Dr Shih said.
“We also found more than half (56 per cent) did not state that they offered any form of pre or post-test consultation, which is concerning.”
Sociologist Dr Patti Shih from the Australian Centre for Health Engagement Evidence & Values
The study was conducted within the Wiser Healthcare NHMRC Centre for Research Excellence collaboration, which included University of Sydney researchers Associate Professor Fiona Stanaway and Associate Professor Katy Bell. It revealed just 30.6 per cent of tests provided limited clinical utility; 41.9 per cent were non-evidence-based commercial health checks; and 16.7 per cent were tests whose methods and/or target conditions are not recognised by the general medical community. Half (51 per cent) of the DTC tests did not report analytical performance of the test or laboratory accreditation.
Dr Shih said the harms of DTC tests clearly outweigh the benefits.
“When you’ve got people ordering or performing their own tests, there are a lot of potential harms they can experience. This can be because of errors – for example, being told they have a condition when they don’t, because the test isn’t managed in an accredited lab. It can be because of unnecessary diagnosis – if you do lots of tests on a healthy person, you will often find something, and you can suddenly have ‘a condition’ that would never have caused you problems,” Dr Shih said.
“People can also be harmed if they make treatment decisions based on tests that have no evidence to support them, so will give you unhelpful or misleading information. And some of these tests cost a lot of money, especially the ones that were most unnecessary and inappropriate.
“Testing is also resource intensive and produces medical waste, another consideration we need to question.
“The size of the DTC test market in Australia is growing and at the end of the day it is mostly healthy people who are using these tests and they’re the people least likely to need them.”
Dr Shih would like to see improved regulation of the industry and said there must be higher standards of evidence required to show the clinical benefit and efficacy for DTC tests.
“We would like to see consumer-led reporting systems introduced so patient safety and test results are adequately followed up by health professionals,” Dr Shih said.
“It’s important that people aren’t pushed by marketing to buy and use these kinds of tests unnecessarily, we need better reporting of health outcomes for DTC tests and more decision-support resources for consumers.”
Dr Shih has also co-authored an article in The Conversation that outlines four questions to ask before you buy a test online.
UOW is committed to working towards the United Nations Sustainable Development Goals which provide a shared blueprint to achieve a better and more sustainable future for everyone. This research addresses Goal 3, Good Health and Wellbeing, and Goal 11, Sustainable Cities and Communities.
About the research
Direct-to-consumer tests advertised online in Australia and their implications for medical overuse: Systematic online review and a typology of clinical utility is published in BMJ Open and can be accessed at: https://bmjopen.bmj.com/content/13/12/e074205
The authors on this multidisciplinary study include UOW researchers Dr Patti Shih, Dr Pauline Ding, Professor Stacy Carter; University of Sydney researchers Associate Professor Fiona Stanaway and Associate Professor Katy Bell (the study’s senior author); pathologists Professor Rita Horvath, Dr Daman Langguth, Associate Professor Mirette Saad and chemical biologist Dr Andrew St John.
