23andMe gets FDA nod to provide genetic information again
The US Food and Drug Administration had previously halted the company's test, which can show the potential risk of hereditary diseases.
Biotech company 23andMe has been cleared to let actual and future parents in the US know if they might be at risk of passing a disease to their children, all with a simple spit test.
The Food and Drug Administration gave the Mountain View, California, startup permission to resume supplying health information and analysis gleaned from its customers' DNA this week. 23andMe previously offered information on a person's ancestry before the FDA halted its operations.
The approval means the company's US customers will now be able to use inexpensive testing kits to determine their "carrier status," which looks at whether they possess a gene mutation that, when combined with an identical gene mutation in a partner, puts them at risk of passing any of up to 36 hereditary diseases to their children.
While genetic testing isn't new, it isn't routine or cheap. 23andMe offers kits priced at $199, which allows the company to bring the services to mainstream.
"This is an incredibly dynamic time in genetics and we're excited to be at the leading edge of bringing genetics directly to individuals as they begin to learn about their 23 pairs of chromosomes," said 23andMe co-founder and CEO Anne Wojcicki in a statement.
The test will also tell people whether they are predisposed to a whole list of traits, from male pattern baldness to lactose intolerance.
23andMe is not the only personal genome testing company, but it is the best known and is considered to be one of Silicon Valley's big success stories. The company is backed by Google, and Wojcicki is also the wife of Google founder Sergey Brin (the two are separated).
October has been a good month for the startup, which last week raised $115 million in funding. Then came this news of the FDA's decision -- a success for the company, following nearly two years of negotiations with the regulator.
But it is also something of a compromise for the company, which outside of the US offers a much more wide-ranging health profile to customers. In 2013 23andMe was told by the FDA, which strictly regulates consumer health products, that it had to cease feeding customers information about their health gleaned from examining their DNA. The regulator was concerned that results could lead people to believe they had certain diseases, when in fact they didn't. Since then, 23andMe customers in the US have only had access to results about their genetic heritage.
The FDA's decision has reinstated access to only limited elements of what was previously a highly detailed health profile. Meanwhile, 23andMe customers in the UK still have access to a more detailed range of results. This includes information about how genetics might affect reactions to certain drugs and whether a person is themselves at risk of developing disease.
The scope of 23andMe's health profiling may be more limited in the US, but it is also the only company that has gained FDA approval to deliver health results from DNA tests direct to consumers. The company has also promised a different experience with new tools for customers by the end of the year.