Professor Diane Hoffmann publishes article in Science

All News
The DTC microbiome testing industry needs more regulation
Tests lack analytical and clinical validity, requiring more federal oversight to prevent consumer harm
A growing body of research has suggested the potential for improving human health by better understanding the human microbiome. This research has led to the emergence of a global industry selling direct-to-consumer (DTC) microbiome testing services. Regulation of this industry has been generally ignored despite its having made a mark on the lifestyle health and wellness market. Yet companies’ claims of having the ability to detect “abnormal” microbiomes are not substantiated by research; the testing processes lack analytical validity, and the results have no demonstrated clinical validity. As a result, consumers may be financially exploited or harmed by inappropriate use of test results that neither they nor their doctors understand. To address concerns over such potential harms, we conclude that regulators should develop requirements for the industry to document and demonstrate the consistency and validity of methods and claims...

Read the entire article

Go to Science