California-based 23andMe, Inc., has been ordered by the U.S. Food and Drug Administration (FDA) to stop selling its personalized DNA test kits. In a warning letter that has been posted online, the federal agency asserts that 23andMe has not proved that there is a scientific basis for its technology. The letter refers specifically to the 23andMe Saliva Collection Kit and Personal Genome Service (PGS). The company has claimed that its products can identify risk for more than 250 diseases and health conditions, and by law such claims can only be made about tests that have been cleared by the FDA.
Google-backed 23andMe is one of a number of startups that sell genetic information, so the fact that it is in a dispute with the FDA may have significant implications for other companies and for the industry in general. In issuing the warning letter, the FDA is rejecting the company’s longstanding claim that it is not providing a medical service through its products, but merely providing information for consumers. Last year, 23andMe changed its strategy to a degree, submitting several disease-specific tests for approval—approval that apparently has not been won. The FDA expressed concern, for example, with the company calling its saliva-based test kit a “first step in prevention” against diabetes and other diseases.
The company took a conciliatory tone in its public response. A spokesperson acknowledged that “we have not met the FDA’s expectations” and continued, “Our relationship with the FDA is extremely important to us, and we are committed to fully engaging with them to address their concerns.” The situation is a developing one that bears watching. Read the FDA warning letter.