In the end, the secret sauce behind Thursday’s milestone announcement by the Food and Drug Administration to permit 23andMe to market genetic tests for diseases directly to consumers was hard-earned trust.
Now the company will be able to include information on the genetic predisposition for 10 important conditions or diseases — including Parkinson’s and late-onset Alzheimer’s — from a single saliva test that costs $199. The move comes four years after FDA banned 23andMe from selling such data, forcing it back to the drawing board. With exceptions for some tests, such as the genetic marker for breast cancer that often leads to surgical intervention, the agency intends to let the company offer similar tests without premarket review — a landmark for the genetic testing industry as a whole.
