Direct-to-consumer (DTC) microbiome tests lack analytical and clinical validity and require more federal regulation to prevent consumer harm, according to a commentary published in the journal Science. A growing body of research suggests that a better understanding of the microbiome has the potential to improve health, and this has spawned a global industry selling DTC microbiome services.

However, despite the burgeoning impact of the industry, regulation of DTC microbiome testing has been virtually ignored. Companies’ claims of having the ability to detect “abnormal” microbiomes are not substantiated by research and lack oversight. “As a result, individuals may be financially exploited or harmed by inappropriate use of test results that neither they nor their doctors understand,” the authors write.

Although DTC microbiome companies claim they can determine whether an individual’s microbiome is healthy or “out of balance,” and suggest that an unbalanced microbiome could be the reason for one or more health issues, given the lack of oversight, some companies could knowingly mislead the public.

On the basis of findings derived from each company’s proprietary algorithms, which are said to determine whether an individual’s microbiome is healthy or not, the company may suggest buying their products or undergoing further testing to track improvement.

Consumers may be misled to believe these products are regulated and may substitute critical medical treatment for unregulated, unproven alternatives. “To address concerns over such potential harms,” the authors say, “we conclude that regulators should develop requirements for the industry to document and demonstrate the consistency and validity of methods and claims.” Such efforts are underway, but will likely take years to achieve results.

To read the abstract of the commentary, published in Science, click here