FDA, 23andMe Respond to Gene-Drug Test Article

"But with genetic testing, it's still early, and we've got a chance to do it right."....very well possible and what stance will the FDA take? It's going to totally uproot many of the ways they have done business over the years, and the public will demand answers quickly....and regulation...BD

After decades of anticipation, the age of personalized, gene-based medicine is nearly here. But how good are its recommendations? And when a test tells you what drugs to take, how can you be sure that the science is solid?

23andMe aside, pharmacogenetic testing in some cases appears to be running ahead of the science supporting it. And that may be why regulation is so important.

Perhaps the companies are right -- but what if they're not? What if they're wrong next time? Some analysts -- such as the Center for Genetics and Public Policy authors of a Science article that prompted my own coverage -- say the government needs to set and enforce clinical standards for gene-drug interaction tests. The companies themselves appear open to this; they know that a few high-profile mistakes could scare customers away. The big question, then, is whether the FDA will follow their advice.