The United States Food and Drug Administration is not known for its prose. So the warning letter that it sent to 23andMe, the direct-to-consumer genetic-testing company, on November 22nd, was a surprise in more ways than one. “It reads like the letter of a jilted lover,” Misha Angrist, a former genetic counsellor who writes about personal genomics and teaches at Duke University, said.
Nearly everyone remains mystified that 23andMe stopped communicating with the F.D.A., even as the company launched new marketing campaigns and claims. One theory is that the company, convinced that the F.D.A. is incompetent, is trying to provoke agency to overreach so it can then outmaneuver it.
Another possibility is that the company simply dropped the ball.
Read the full, original story here: THE F.D.A. VS. PERSONAL GENETIC TESTING