Running Afoul of Regulators

23andme, the popular genetic testing website, has received a cease and desist letter from the FDA. The gist of the letter is that they have not provided evidence that their test works. And, the FDA also worries that the general public does not have the scientific background to interpret the results. For instance, if a woman does not carry the BRCA gene, does that mean that mammograms are not necessary?

Another take on the ‘no evidence’ by John Wilbanks is that 23andme is sitting on some dynamite data (or not). His piece touches on open data.

FDA Warning Letter
November 22, 2013

FDA warns maker of genetic-testing kit
Brady Dennis | Washington Post
November 25, 2013

The FDA said the company repeatedly has failed to provide the scientific data necessary to prove that its test works as advertised.

Perhaps more significantly, the agency’s action underscores its unease about the potential consequences of direct-to-consumer genetic tests, which can provide people with detailed information but not necessarily the context necessary to interpret what it means or how they should proceed.

It also highlighted a contentious debate that has unfolded in recent years over how and whether the government should police an individual’s access to information about his or her genes.

FDA Tells 23andMe to Stop Marketing DNA Kits; 23andMe Says It’s Sorry for Being Slow
Liz Gannes | All Things D blog (allthingsd.com)
November 25, 2013


23andme gets a nastygram for the holidays

John Wilbanks | Del-Fi Blog (http://del-fi.org/)
November 25, 2013
“But since 23andme won’t tell anyone, we don’t know which way. This fits into a general pattern of espousing open science while not practicing it for the company.”

FDA slaps personal genomics startup 23andme with stiff warning
Dan Munro | Forbes
November 25, 2013

The curious case of 23andMe
Ryan Bradley | CNN Money
November 26, 2013

And here are two articles from the past on 23andme:

What Are Genomic Testing Firms Like 23andMe Really After?
Shannon Brownlee | Mother Jones
December 2009

Consumers Slow to Embrace the Age of Genomics
Andrew Pollack | New York Times
March 19, 2010

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