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The genetic testing company 23andMe became a Silicon Valley sensation by providing consumers with health and ancestry information based on a sample of their saliva, but suffered a setback when the Food and Drug Administration told it to stop presenting health data in 2013.
Now, after nearly two years, 23andMe is announcing on Wednesday that it will begin providing customers with health information again, though much less than before and with F.D.A. approval.
The company hopes the information, which relates to the risk of passing certain inherited diseases to oneâs children, will reignite growth in its subscriptions â even as the company evolves from being just a consumer testing service into a drug developer. It has also revamped its website to make the genetic information easier to understand and is raising the price of its service to $ 199, from $ 99.
âPart of what we tried to do over the last two years is take advantage of being off the market to redesign the entire experience,â said Anne Wojcicki, co-founder and chief executive of 23andMe.
The company, based in Mountain View, Calif., initially offered consumers information on their risks of developing various diseases based on an analysis of the DNA in their saliva sample. The company created a buzz with its celebrity-filled âspit partiesâ and its message that consumers have the right to their own genetic information, without a doctor or regulatory agency being involved. It did not hurt that Ms. Wojcicki, now divorced, was married at the time to Sergey Brin, a co-founder of Google, and that Google invested in her company.
But in November 2013, the F.D.A. demanded that 23andMe stop providing health information until it could obtain regulatory approval by demonstrating that its results were accurate.
The setback was somewhat similar to what is occurring now with Theranos, another hot Silicon Valley medical testing company run by an entrepreneurial young woman, Elizabeth Holmes. In articles last week, The Wall Street Journal raised q uestions about Theranosâs accuracy (the company says the doubts are unfounded), and the F.D.A. has asked the company to stop using its method of drawing blood from a finger instead of the arm until it wins regulatory approval for the device used.
The new health-related information 23andMe will provide is called carrier status. That relates to whether people have genetic mutations that could lead to a disease in their offspring, presuming the other parent has a mutation in the same gene and the child inherits both mutated genes. There will be information on 36 diseases, including cystic fibrosis, sickle cell anemia and Tay-Sachs.
Whether that information, which is of most interest to people planning to have babies, will be compelling is unclear, and there are separate carrier tests available through doctors from other laboratories.
Ms. Wojcicki said 23andMe still hoped to gain F.D.A. approval to provide information on health risks, but she would not estimate how long it might take to win that approval.
From a rebel fighting the system, she said, 23andMe is now âworking from within the system and saying the consumer will have a sense of ownership and a voice in that system.â
Ms. Wojcicki said that when the company stopped providing health information, the rate of new customer sign-ups dropped by more than half. The company continued to offer information on ancestry and nonmedical traits such as eye color, ear wax composition and lactose intolerance.
But the business still grew. This year it surpassed one million users, compared with half a million at the time of the F.D.A. action. She declined to disclose the current figure.
Many of the customers allow their genetic information to be used for medical studies, and some also provide additional information, such as what diseases they have. Companies like Pfizer and Genentech are paying 23andMe to use the data to search for insights that could be useful in developing drugs.
In May, 23andMe decided to go into drug discovery and development itself. That effort is being led by Richard Scheller, who had headed research and early development at Genentech.
Many earlier genomics companies, including Celera Genomics and DeCode Genetics, also tried their hand at drug development. Companies can make much more money from a successful drug than from selling genetic data. But drugs are also riskier and costly to develop, and many of those early attempts failed.
Ms. Wojcicki said 23andMe hoped to learn from those previous failures. She said that pharmaceutical companies would prefer to license an experimental compound rather than just acquire raw data.
The company recently raised $ 115 million from investors, led by Fidelity Management & Research, bringing its total raised to $ 241 million. Ms. Wojcicki said that 23andMe was not yet profitable and that the investment in drug development might prevent it from turning a profit in the short term.