Experts argue in The BMJ today that improved information and regulation are crucial to shielding consumers from the potential dangers of tests marketed directly to them. Emma Gram from the University of Copenhagen, alongside her colleagues, raises concerns that consumers may purchase more harmful than beneficial products. They emphasise the necessity for high-quality information and effective communication to guard against unbalanced and misleading marketing strategies.

The rapid progress in diagnostic technology and digital health has expanded the array and volume of direct-to-consumer (DTC) tests. These range from self-test kits and multi-cancer detection tests to testosterone and food sensitivity tests. Sales of these tests in the United States have escalated dramatically, from $15 million in 2010 to $1.15 billion in 2022. However, there needs to be a dedicated regulatory framework to oversee the appropriate use of these burgeoning products.

The authors highlight specific tests, such as those indicating menopause or fertility chances, which may deliver incorrect or misleading information to women about their fertility or symptoms. They note that while the availability of self-testing kits could encourage communities that are typically underserved, such as those at high risk of sexually transmitted infections, to access testing more readily, the inaccuracies in these tests could lead to mismanagement. False positive results might prompt unnecessary follow-up consultations and further testing, while false negatives could delay necessary treatment by offering false reassurance.

Furthermore, the instructions, packaging, and advertising accompanying these tests sometimes require accurate completion, leading consumers to make uninformed decisions regarding their health. Tests marketed for assessing “wellness,” such as hormone levels, may also present significant risks. Abnormal results, which may not be clinically important, could cause distress, lead to excessive testing, or result in the use of unproven supplements and treatments, posing serious health risks, including issues with fertility and cardiovascular conditions.

The marketing strategies often target healthy individuals, who are the least likely to benefit from these tests. The potential harms of multi-cancer detection tests are particularly significant. Currently marketed and sold in the US, these tests claim to detect over 50 types of cancer before symptoms appear. However, Gram and her team argue that they are more likely to detect cancers at a late stage, potentially causing considerable harm without providing tangible benefits.

While acknowledging that DTC tests could benefit certain situations, the authors note that studies have yet to prove their use improves health outcomes. Professional organisations advocate for tests to offer clear interpretations and results in response to these potential consumer harms. They also call for patients to be well-informed about when self-testing is advisable and when it is not. Nevertheless, with formal policy directives and regulations of commercial suppliers operating outside the traditional healthcare system, progress in implementing these changes could be more active.

The authors conclude that current regulatory frameworks are insufficient to address the novel ways DTC tests are sold and used. They insist that commercial suppliers must demonstrate the benefits of their products, including clearly defining the appropriate targeted populations for the tests to avoid harmful misinterpretations. Additionally, they urge industry and regulatory bodies to consider broader concepts of harm, including financial, psychological, and physical harm, as well as the risks of overdiagnosis and ineffective diagnosis associated with DTC testing.

More information: Emma Grundtvig Gram et al, Direct-to-consumer tests: emerging trends are cause for concern, The BMJ. DOI: 10.1136/bmj-2024-080460

Journal information: The BMJ Provided by BMJ Group