WHEN does a personal genome scan count as a medical device? That’s the question hanging over firms that offer assessments of health risks based on people’s DNA.
On 10 May, the US Food and Drug Administration sent a to the latest entrant to the market, of San Diego, California, suggesting that its genome scans are medical devices and so need the agency’s approval.
Pathway seems to have come to the FDA’s attention as a result of a plan to sell its test over the counter at pharmacies, which is now on hold. But the agency’s move will affect other companies too. “This policy does apply to companies selling similar tests, whether online or in physical stores,” says FDA spokesman Dick Thompson.
Advertisement
It is still unclear whether the FDA has the legal authority to demand that genome scans are submitted for its approval.
of Mountain View, California, has long maintained that its scan is an “informational service”, not a medical test. , based in nearby Foster City, is already talking to the FDA about its scans.
“23andMe says its genome scan is an information service, not a medical test”
