As for the actual tests, there is little government oversight, she continued. “Most genetic tests are provided by clinical laboratories, and the laboratory director decides when to offer the tests and what tests to offer.
“Labs are subject to general quality standards, but these are not genetic test-specific. Of the more than 800 tests currently out there, only a handful are regulated by the [Food and Drug Administration]. Indeed, FDA provides more oversight for home pregnancy tests than it does today for most genetic tests,” she said.
Steve Gutman of the FDA's Office of In Vitro Diagnostics, who was in the audience, said that the FDA is “not disinterested” in this area.
The agency “is not unaware of very colorful array of forces that are operating here, and it does not have easy answers. The unanswered question is how the FDA might move from the small set of commercial tests it now regulates to broader regulation of building blocks of home-brewed tests or the home-brewed tests themselves.
“I can't make any promise about timelines, but I can make a promise that the last chapter hasn't been written. It's a novel in progress,” he noted