FDA orders 23andMe to “discontinue” genetic tests

Google-backed 23andMe has been ordered to “immediately discontinue” marketing its Personal Genome Service (PGS) by the US Food and Drug Administration (FDA).

23andMe is a DNA analysis service that provides information and tools to the general public to learn about and explore their individual DNA. For £61, users receive a kit allowing them to take a sample of saliva, which is then sent back to the company and a readout of the users genetic code is sent in return. The website states the service can provide “health reports on 254 diseases and conditions“.

However, according to the FDA, 23andMe has not supplied vital information to back its marketing claims – it must provide proof about how accurate its detection methods are as well as supplying the error rates from its PGS.

In a letter made public on the 25th November, the FDA states that they are imposing the ban and sending this letter “because you [23andMe] are marketing the 23andMe Saliva Collection Kit and Personal Genome Service (PGS) without marketing clearance or approval in violation of the Federal Food, Drug and Cosmetic Act (the FD&C Act)”.

“FDA is concerned about the public health consequences of inaccurate results from the PGS device – the main purpose of compliance with FDA’s regulatory requirements is to ensure that the tests work,”

Alberto Gutierrez, director of the FDA’s centre for devices and radiological health, says in the letter.

 

The start-up company was created in 2006 and was co-founded by Anne Wojcicki, the wife of Google co-founder Sergey Brin.

“We have received the warning letter from the Food and Drug Administration. We recognize that we have not met the FDA’s expectations regarding timeline and communication regarding our submission. Our relationship with the FDA is extremely important to us and we are committed to fully engaging with them to address their concerns.”

Statement on 23andMe’s website from 25th November 2013.

 

 

Related news:

FDA bans 23andme personal genetic tests (BBC News)

FDA orders genetics company 23andMe to cease marketing of screening service (The Guardian)

Reference links:

FDA letter to 23andMe

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