The US FDA just sent out more letters to genomic testing firms asking them to explain why their testing kits should not be regulated. The companies in question (and their target market) were Lumigenix (disease predisposition), American International Biotechnology Services (AIBiotech, workout optimization for athletes and also disease predisposition), and Precision Quality DNA (PQDNA, disease predisposition and drug response).
Based on the blogosphere reaction, the testing of genomic influences on athletic performance drew the most attention. I don’t know much about genetic influences on athletic performance, but I don’t think anyone else does either. Hence the reaction to such a product—is there really any value there? I already have to submit a copy of my son’s birth certificate to enter him in certain sports tournaments. Am I also going to have to submit his genetic profile so he can join AYSO?
For all three it appears to me that the FDA was pretty reasonable in exercising its mandate to protect the public health by blocking unreasonable medical claims for products. It’s unfortunate for those companies that are trying to do the right thing by backing up their genetic testing services with real data; they may well have to carry the burden of federal regulation soon.