The DTC microbiome testing industry needs more regulation
成果类型：
Editorial Material
署名作者：
Hoffmann, Diane E.; von Rosenvinge, Erik C.; Roghmann, Mary-Claire; Palumbo, Francis B.; Mcdonald, Daniel; Ravel, Jacques
署名单位：
University System of Maryland; University of Maryland Baltimore; University System of Maryland; University of Maryland Baltimore; University System of Maryland; University of Maryland Baltimore; University System of Maryland; University of Maryland Baltimore; University of California System; University of California San Diego; University System of Maryland; University of Maryland Baltimore; University System of Maryland; University of Maryland Baltimore
刊物名称：
SCIENCE
ISSN/ISSBN：
0036-12253
DOI：
10.1126/science.adk4271
发表日期：
2024-03-15
页码：
1176-1179
关键词：
摘要：
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.