To our readers:
On November 22, 2013, the Food and Drug Administration sent a letter to Anne Wojcicki, CEO and co-founder of 23andMe, ordering the company to halt sales of its genetics test kits. The FDA gave 23andMe 15 working days to respond. The FDA’s concerns were: to make certain 23andMe’s procedures were accurate and to be assured individuals were not using 23andMe’s tests as substitutes for professional medical advice.
23andMe responded to the FDA’s warning letter with the following statement: "We have received the warning letter from the Food and Drug Administration. We recognize that we have not met the FDA's expectations regarding timeline and communication regarding our submission. Our relationship with the FDA is extremely important to us and we are committed to fully engaging with them to address their concerns."
Bioinformatics is a new and innovative application of science and technology. No matter what develops as a result of the letter, there is little doubt regarding the bigger point: new analytical techniques combining advances in computing, and in our understanding of genetics, will become important components of the medical diagnosis and treatment landscape. As with any new technology and company, there are always bumps in the road. We anxiously await answers to the warning letter and will defer judgment about 23andMe until the FDA has made their determinations.