23andMe, a genetics testing company, has been given the green light by the Food and Drug Administration (FDA) to resume providing U.S. customers with health information based on their DNA tests. The Silicon Valley-based biotech company was forced to stop providing health data from personal genome testing after it failed to receive market authorization from the FDA over concerns that its results might be inaccurate.
Two years on, 23andMe has announced that they will be able to fully resume their services in the U.S. after obtaining FDA approval. For the past two years, the company was still able to sell information about ancestry but was barred from releasing data on health and carrier status. Along with this good news from the FDA, 23andMe got a sleek new website and a $115 million (£75 million) injection of cash from investors last week
Talking to The Associated Press, Anne Wojcicki, the company’s co-founder and CEO, said, "Today we've successfully established a framework for working with the FDA to bring back reports directly to the consumer. And we'll continue to work to try and bring all of this information back."
She added, "We took a lot of the feedback that we'd gotten over the last seven years and then incorporated that with all the FDA feedback into a whole new report format.”
The company name, 23andMe, comes from the 23 pairs of chromosomes in humans. Using DNA taken from spit, the company can give you information on whether you are a carrier for inherited conditions such as cystic fibrosis, sickle cell anemia and hereditary hearing loss. As well as continuing their ancestry services, they can now also provide reports of whether you're likely to get an alcohol flush reaction, your probability for enjoying caffeine and your muscle composition.
The company has been able to sell ancestry and health-based information in Canada since October 2014 and in the United Kingdom since December 2014.
However, there have been some changes to their original service. First of all, it appears their services will be made more expensive, going from $99 (£65) to $199 (£130). Additionally, it will not be able to sell all of the 250 reports included in its original service, which purportedly told users if they were genetically susceptible to diseases such as Parkinson's and Alzheimer's.