FDA Bans Controversial Genetic Home Testing Kit

Dennis Faas's picture

The United States Food and Drug Administration (FDA) has banned a $99 genetic home testing kit. The agency says the company responsible for the kit, '23andme', failed to prove its marketing claims and insists that the product could put customers' mental and physical health at risk.

23andme was founded by Anne Wojcicki, the wife of Google co-founder Sergey Brin. The company's kit allows users to collect a saliva sample and send it in for genetic analysis.

The company then provides a report that can be used for tracing family connections. It also includes details about 240 health conditions that could affect the customer. (Source: 23andme.com)

23andme adds that it will hold on to saliva samples and will contact customers with new information as and when genetic science advances. By making such claims, 23andme's product is legally classified a medical service.

Genetic Kit Makes Bold Health Claims

But the FDA has its doubts about the legitimacy of 23andme's product. Specifically, the agency says it's concerned that 23andme's genetic findings will result in people making rash health decisions without seeing a qualified medical professional.

That could result in significant mental anguish or people pursuing and receiving unnecessary (and expensive) treatment. (Source: fda.gov)

Company Has Received Numerous Warnings

The ruling won't come as much of a surprise to 23andme. The Food and Drug Administration says it has discussed the issue with the company in fourteen face-to-face (or teleconferencing) meetings, "hundreds" of email messages, and "dozens" of phone calls.

However, the FDA says it still hasn't been shown clear proof that 23andme's tests actually work.

The Food and Drug Administration has now decided that it will be illegal for 23andme to market its product until the FDA grants final approval. The FDA also warns that if it doesn't hear from 23andme within 15 days with a clear timetable for addressing and resolving the problem, it will begin taking legal action.

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