US regulators granted Silicon Valley biotech firm 23andMe permission to become the first company to market reports showing customers’ health risks based on their genetics.
The first reports will be made available this month in the United States, indicating genetic propensities for conditions such as Parkinson’s disease and late-onset Alzheimer’s disease, according to the Food and Drug Administration.
“Consumers can now have direct access to certain genetic risk information,” said Jeffrey Shuren, director of the FDA’s Center for Devices and Radiological Health.
“But it is important that people understand that genetic risk is just one piece of the bigger puzzle, it does not mean they will or won’t ultimately develop a disease.”
23andMe extracts genetic data from saliva samples sent in by customers.
The private company had been focusing on providing ancestry information after the FDA reined in efforts to offer genetics-based health information about four years ago.
“I am proud to say we are the first and only company to receive FDA authorization to market genetic health risk reports without a prescription,” said 23andMe co-founder and chief Anne Wojcicki, the ex-wife of Google co-founder Sergey Brin.
“It’s a defining moment — giving individuals direct access to more information about how their DNA could impact their health.”
The FDA said it granted permission for 23andMe to market “personal genome service genetic health risk” tests for ten diseases or conditions in a first-of-its-kind service direct to consumers.
Test results could help people make more informed decisions when it comes to lifestyle or spur more insightful discussions with health care providers, according to the FDA.
The agency stressed that factors other than genetics, such as lifestyle and pollution, play roles when it comes to health. The 23andMe tests were specifically barred from serving as the sole basis for major medical treatment decisions, the FDA said.
23andMe was founded in 2006 and is based in Mountain View, California, where Google also has its headquarters.
The 23andMe “Health + Ancestry” report costs $199. A genetic test focused on ancestry alone is $99.
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