How a tiny genetics startup that was practically crushed by the FDA transformed itself into a $1.1-billion powerhouse

Anne Wojcicki 23andme CEO google23andme.com23andMe co-founder and CEO Anne Wojcicki

Almost two years after the FDA stopped consumer genetics company 23andMe from providing its direct-to-consumer health reports, the company is still very much alive and kicking.

The company announced Wednesday that it had just completed a $US115 million round of funding, led by the Fidelity Management & Research Company.

Forbes reports that this round values 23andMe at $US1.1 billion, making it the highest-valued personal genetic testing startup in the world.

The Mountain View, California-based company, which was founded in 2006, is known for its $US99 genetic test kits. Customers who use the kits send in a sample of spit. Then, 23andMe’s labs isolate the DNA in the sample and scan it for single genetic variations that are linked to specific traits like hair and eye colour, susceptibility to certain diseases, and ancestry.

In November 2013, the FDA barred 23andMe from sending any of that data related to health to customers because of concerns that the company was misrepresenting genetic tests as medical advice. Providing information about things like your risk for developing type 2 diabetes or certain kinds of cancers, for example, was banned. With half of its product put on hold by the FDA, the company looked as if it was on the verge of falling apart.

But 23andMe’s recent developments suggest this may not be the case.

This year, the company announced it would begin to research possible ways to treat the conditions its genetic test was diagnosing, launching a new trend for data companies. The company also announced partnerships with major drug companies, including pharmaceutical giants Genentech (Roche’s US unit) and Pfizer, both of which have market caps of more than $US200 billion. Those partnerships will compile the genetic info from 900,000 consenting users into databases that could be used by the drug companies to develop potential treatments for certain diseases.

In February, 23andMe also received FDA approval for a rare inherited condition called Bloom Syndrome, which is linked with an increased risk of cancer. 23andMe has said that it won’t provide the health reports again until it gets approval for a larger set of tests, though they’re still collecting all of that raw genetic data.

23andMe said in a news release that the company plans to use the funds to build up their global presence and focus on drug development.

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