23andMeThe provider of affordable genetic tests for the masses has been one of the great comeback stories in medtech.

October 19, 2016

1 Min Read
2016 Medtech Company of the Year Finalists: 23andMe

23andMe

23andMe resumed selling its home genetic tests last year.

The provider of affordable genetic tests for the masses has been one of the great comeback stories in medtech. In 2013, 23andMe faced an especially scathing FDA warning letter that accused it of marketing its tests to provide "'health reports on 254 diseases and conditions" that could potentially cause people to make medical decisions that were not in their interests. As a result, the Silicon Valley company had to scale back its offering to ancestry tests. 

CEO Anne Wojcicki, though, made resolution with FDA a priority.

"It was just a question of saying, 'You know what? We entirely need to refocus. We need to hire the right people. We had a major miscommunication. We need to make sure we're executing the right way," she told Bloomberg last year.

The company over time has been able to reintroduce consumer genetic tests related to health, this time with FDA's blessing. The company's $199 health and ancestry test, for example, lets customers know whether they are carrying genes related to cystic fibrosis, sickle cell anemia, and hereditary hearing loss. 

[image courtesy of 23ANDME]

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