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 letter to the latest entrant to the market, Pathway Genomics 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…
