Will Allow 23andMe to Sell Genetic Tests for Disease Risk to Consumers -
By GINA KOLATAAPRIL 6, 2017
For the first time, the Food and Drug Administration said it would allow a company to sell genetic tests for disease risk directly to consumers, providing people with information about the likelihood
that they could develop various conditions, including Parkinson’s and Alzheimer’s.
allowed the company to tell customers if they had a copy of a mutated gene for a disease like cystic fibrosis
that would not affect them — you need two copies of such mutated genes to get the disease — but could affect their future children.
Until now, the only way for people to get such genetic tests was to see a medical
professional who would order a test and later deliver the results to patients.
If a person with one copy of a cystic fibrosis gene, for example, has children with a partner who also has one
copy of the mutated gene, each child has one chance in four of inheriting a mutated gene fromeach parent.
People often need genetic counseling before deciding they want to know if they are at risk for
Parkinson’s disease, said James Beck, chief scientific officer of the Parkinson’s Foundation.
This is not the first foray by 23andMe into direct-to-consumer disease risk testing; several years ago it marketed tests
to consumers claiming it could provide genetic information for a variety of diseases from a simple saliva sample.
