The FDA has told the DNA analysis company 23andMe that it must “immediately discontinue” the marketing of its signature product, the $99 Saliva Collection Kit and Personal Genome Service, or PGS, due to a lack of “marketing clearance or approval.”
The PGS provides people “health reports on 254 diseases and conditions.”
In a warning letter made public today the FDA described its concern about “the potential health consequences that could result from false positive or false negative assessments.” In the case of a false positive report, a patient might undergo surgery or other “morbidity-inducing actions,” the agency wrote, “while a false negative could result in a failure to recognize an actual risk that may exist.”
What’s the Big Idea?
The FDA letter notes its “long history of working with companies to help them come into compliance with the FD&C Act.” Statements from 23andMe indicate the company’s desire to come into compliance. We don’t know how this particular matter will be resolved, but we do know this issue is not going away. In fact, Bloomberg notes that genetic tests may become a $25 billion annual market in the U.S. within a decade.
highlights the tension between the paternalistic medical establishment that arose to deal with the dangers of 19th-century quack medicine, and a “techno-populist” element of American society pioneering personal health assessment and decision-making by leveraging new information technologies. Caught between them is the general public, which trusts institutions but is obviously intrigued by the offerings of consumer medicine, as judged by units sold of 23andMe’s kits.
In the video below, Anne Wojcicki, co-founder of 23andMe, tells Big Think that people should have access to anything that is fundamentally theirs.
Watch the video here: