US genetic testing company 23andMe has been given limited FDA approval to provide inherited disease profiles for customers, after some of its operations were suspended in 2013.
On Wednesday company CEO Anne Wojcicki announced that the FDA had authorized the supply of tests for inherited diseases, in addition to profiling customer ancestry and personal traits.
“We’ve worked with the FDA for nearly two years to establish a regulatory path for direct-to-consumer genetic testing. We are a better company with a better product as a result of our work with the FDA”, Wojcicki said in a statement.
The company will now provide customers, who submit a saliva sample and pay US$199, health reports on 36 inherited conditions, such as cystic fibrosis and sickle cell anaemia.
Customers will receive a breakdown of their genetic predispositions, including non-medical inherited traits such as bitter-taste perception, lactose intolerance and even cosmetic characteristics such as cheek dimples or curly hair.
But the company’s new test will not screen for conditions that raised the most concerns last time around, including heart attack, asthma and hip fractures.
“The new product focuses on carrier mutations, or specific gene changes, known to cause health issues when children receive the mutations from both parents,” Brian Zikmund-Fisher at the University of Michigan School of Public Health, told New Scientist. “Issues like behaviour and environment don’t generally matter for these diseases. If environment and behavior do matter, they matter in determining how and when a condition shows itself, not whether it will happen.”
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