Two years after the FDA cracked down, the Silicon Valley start-up of the health restoring its direct-to-consumer tests.
23andMe Anne Wojcicki CEO in 2014.
(Stephen Lam / Reuters)
In November 2013, 23andMe suffered a crushing blow: Food and Drug Administration (FDA) banned the DNA-testing company by providing health-related information on the basis of its genome scan, a fundamental part of their business. Almost two years later, the Silicon Valley start-up is making a comeback with a slimmed-down version of the service, this time with official permission.
New users will have access to the service immediately converted, and existing customers in the coming months, said Tuesday 23andMe. “This is the revival of direct-to-consumer genetics,” Emily drabant Conley, Vice President of Business Development and Life Sciences, said Buzzfeed News.
revival, of course, a good word for him. While DNA spit kit 23andme in previously tested for more than 200 diseases, traits, and health, the company will now screen for genetic variants associated with 36 diseases, such as cystic fibrosis, sickle cell anemia, and Bloom syndrome. (These tests are usually for people who do not show any symptoms of a genetic disorder, but may be at risk for transmission to their children.) And $ 199 is twice as expensive. But this is the first and only test of its kind that does not require permission from the broker as a doctor or a genetic counselor.
Customers who pay for the test 23andMe may enter on the web site to see how they are for a particular view and a more detailed breakdown of their results, and related research, in addition to links to genetic counselors and outreach disease groups. They can also learn about two dozen genetically influenced health factors and physical features such as lactose intolerance, eye color, and the type of earwax. And they can continue to learn about the composition of their ancestry, now with features that make it easier to build a family tree and chat with relatives.
These results will first be made available to people who buy the tests now (it takes four to six weeks to analyze samples). Current customers will upgraded in the next few months.
Much has changed in 23andMe at the end of 2013, when the FDA ordered the company to stop selling its reports to health. “In the beginning, we spoke a different language from the FDA,” said Buzzfeed News President Andy Page. “We do not really skill set internally to interpret the set of messages that came from the FDA. We made mistakes with respect to the regulatory environment and the medical community.”
Since then, Paige says, the company has brought to the leaders with more experience of regulation; 75% of the senior management differs altogether. Under the guidance of the FDA, 23andMe executives say they have tested the new service to thousands of people, to make sure it is clear.
At the same time, 23andMe was looking for other sources of revenue, too. It expanded in the UK and Canada, and genotyping of more than 1 million people. He struck deals with Genentech, and Pfizer, to gain access to the database (80% of customers 23andme to let their data be used for the study). The company also announced plans to become itself a pharmaceutical company with a 20-person team led by former Genentech executive. This month, he raised $ 115 million in the reported valuation of $ 1.1 billion.
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