I have tried to keep my big fat pie-hole shut about the ongoing battle over regulation of personal genomics companies and instead ply you all (my seven readers!) with genomic fluff because 1) I selfishly want to save a lot of the corporate personal genomics stuff for my book; 2) plenty of other folks have weighed in; and 3) I keep waiting for the curtain to fall on this theater of the absurd. Apparently the latter is not going to happen anytime soon:
Ann Willey, director of the Office of Laboratory Policy for New York State, who is both a board-certified geneticist and a lawyer, spoke last week at CHI’s Beyond Genome conference in San Francisco. “I think of this genomic profiling paradigm…as really a star,” Willey said. “By the time we get done regulating it…we’re going to have to force it into a globe and shear off some of its sparkling and promising aspects.”
Willey said regulation of these companies could potentially fall into several different categories, including the practice of medicine, or a laboratory, or information management. “The jury is out, we haven’t decided what it is,” said Willey. “Once we make it a duck, it better quack like a duck. No matter what box we put it in, we put constraints on it… But we don’t want to leave them in no box, because we have no oversight.” Willey said her office regularly sends warning letters to laboratory testing facilities, from tests on human genes to microbial flora. “We’re not picking on this [genome analysis] industry. We really want to make this work.
“But I’m from the government and I can’t always help.”
Hoo wee! Really fills one with confidence, don’t it? I only wish I’d stuck around Beyond Genome long enough to see the show.