Biotech Values

[DewDiligence]

More on the FDA’s 23andMe ruling:

http://www.wsj.com/articles/fda-signals-easier-rule-on-genetic-tests-1424468927

Alberto Gutierrez, director of the FDA’s office of in vitro diagnostics and radiological health, said the dividing line between light and stringent FDA regulation “is risk-based; it’s what people can do with the results.”

With these tests, they are unlikely, for example, to get radical surgery, as is the case with some genetic breast-cancer tests. They won’t take, or forgo taking, a certain critical medicine. They will instead likely get their spouses tested and get counseling about having children.

With a Bloom syndrome test, “the risk that people planning to have children will both get false results is very small,” said Dr. Gutierrez.