Dec. 6 (UPI) -- After being warned by the Food and Drug Administration, California-based 23andMe said it would stop providing customers with information about the health implications of their genetic makeup.
The company, which provides personal genome services and data about diseases customers may be susceptible to, was responding to a letter sent by the FDA last month reprimanding the company for dragging its feet on providing the evidence required for approval of the product.
“We remain firmly committed to fulfilling our long-term mission to help people everywhere have access to their own genetic data and have the ability to use that information to improve their lives,” said Anne Wojcicki, the chief executive of 23andMe and wife of Google founder Sergey Brin.
The agency is concerned customers would make medical decisions based on their analysis, by changing their dosage or type of treatment, without the company having submitted evidence supporting their analyses.
The company said that they will continue take orders for the test but will provide only ancestry and raw data, without interpreting the health implications of the findings.
Customers who purchased the test before the warning letter was issued would still receive the health information and those who bought the product after Nov. 22 may ask for a refund.
23andMe now sells its service, which also offers ancestry information, for $99. It is aiming to grow to 1 million customers by early next year as demand for affordable and comprehensive genetic testing continues to grow.
[FDA] [23andMe]
