Mix-ups fuel debate about regulation of genetic test companies
One woman panicked when the genetic test she ordered over the Internet concluded that her son was carrying a lifethreatening disorder — and that he wasn’t genetically her son. Another woman’s genetic test result was even more stunning: She was a man, it said.
“I thought, ‘Oh my god. Am I really a man?’ ” said Denise Weinrich, 48, of St. Peters, Mo. “DNA doesn’t lie.”
DNA may not lie, but Weinrich was one of 87 people who received incorrect results last month because of a lab mix-up involving customers of testing company 23andMe. The Mountain View, Calif., company says it spotted the mistakes quickly, notified the clients and has taken steps to prevent future errors.
But the blunder has fueled a debate over whether the government should better police the proliferating tests. “It’s come to the point where really there’s a need for some oversight,” Food and Drug Administration official Alberto Gutierrez said.
“If you have things completely unregulated, then you have a Wild West of commercial interests around medical information,” said Robert Green, chief of Boston University’s Center for Translational Genomics and Health Outcomes. “If you over-regulate, you run the risk of stifling innovation in a very dynamic industry.”