Are at-home blood tests a medical innovation, or a solution trying to sell consumers a problem? Michela Perrone The Skeptic

The more information the better, right? Actually, it depends on what we are talking about. When we talk about health, for instance, this assumption isn’t always true.

Although many of us would like to know everything about our condition, not all information is equally accurate and useful. An investigation by the BMJ revealed that in the UK there are a lot of companies that offer blood tests to find out how many healthy years you might have left, or to measure one’s cholesterol level, kidney or liver function, thyroid hormones, vitamins deficiency or sleep problems. All of this comes from just a finger-prick blood sample.

These companies sell kits to use at home: a do-it-yourself service accessible to anyone who can afford it. For less than £200 (the cheapest test can be found for less than £100) you can get an overview of your health condition.

There is a growing market for these products: the whole blood testing industry was worth around $80.50 billion in 2021 and is estimated to grow to $128.45 billion by 2028.

In this way there is an inversion of the diagnostic process: instead of going to a GP, having an examination and then carrying out some tests to confirm the diagnosis, people access tests first, on the basis of generic symptoms – without having the tools to interpret the outcomes (usually the results merely feature asterisks next to abnormal numbers). People can also see these tests online or on television, while medicines can’t be advertised directly to consumers.

Furthermore, as a panel of expert said in an opinion article for the BMJ, there is a problem with the reliability of these tests: the accuracy is 95%, which means that for every 100 tests, 5 results, by chance, will be abnormal even if people are perfectly healthy. When you test a lot of biomarkers in thousands of people, the probability of false positive results increases.

Most importantly, the NHS is effectively paying the cost of these tests: when a patient gets an inaccurate outcome, they go to their GP, creating a double problem. On the one hand the doctor hadn’t prescribed the tests, and probably won’t be able to manage them. On the other hand, they are likely to recommend other blood tests to review the results, overloading NHS care.

In 2019, the Royal College of General Practitioners published a position statement about screening, saying that:

many of the private clinics pass back results to the NHS, often via general practice, to be assessed and followed up. Some private companies even recommend that customers routinely discuss their results with their NHS GPs. This can be an inappropriate use of NHS resources and can have a potentially significant negative impact on primary care.

In general, experts notice that there is a problem of appropriateness: a person without any symptoms shouldn’t undergo screening unless recommended. National guidelines, for instance, suggest a prostate cancer risk test for all men over-50, who are not experiencing any symptoms. The screening should be preceded by a discussion with a GP – yet, there are a lot of private tests available at any age which don’t need any prescription.

Home tests aren’t new: since 2006, Californian company 23andMe has been promising to identify a customer’s ancestry and genetic predispositions from a saliva sample. In 2008, 23andMe was nominated Invention of the Year by Time magazine, and in 2017 they received FDA authorisation to tell consumers their risks of developing ten medical conditions, including Parkinson’s disease and late-onset Alzheimer’s disease. Years later, the company also obtained the permission – with special control – to offer a test that reports three mutations in the BRCA cancer genes.

The company quickly amassed a huge database, which led to pharmaceutical companies expressing interest in partnerships. In 2018, GSK signed an agreement for personalised drug discovery (it will expire next July).

Less successful is the story of Theranos, a biomedical startup based in California. Launched in 2003, the company offered a new technology to analyse blood tests, using a single drop of blood. Theranos got into trouble in 2015, when an investigation by The Wall Street Journal found out that the so-called technology simply didn’t work: a drop of blood wasn’t enough to detect viruses as they claimed.

The founder, Elizabeth Holmes, and the former president Sunny Balwani, were charged with fraud. Holmes was just 19 years old when she founded the company. In addition to lying to investors, the two put the lives of thousands of patients at risk by providing them with inaccurate and incorrect results. Holmes said her dream was to “change health care as we know it”, but she failed.

The verdict came from the jury at the beginning of January 2022: she was found guilty and was sentenced to over 11 years’ imprisonment.

In their article for the BMJ, the expert committee concluded:

People have a right to spend their money how they wish, but regulators should protect the public from unfair practices. The NHS needs to explain robustly the criteria for high quality screening and testing and to explain to consumers when they should be sceptical and what they should question.

Who knows whether the health system will have the strength to do so.

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The growing industry of at-home blood tests claim to offer clarity, but they often just confuse and worry patients, leaving the NHS to pick up the pieces
The post Are at-home blood tests a medical innovation, or a solution trying to sell consumers a problem? appeared first on The Skeptic.