WHEN does a personal genome scan count as a medical device? That鈥檚 the question hanging over firms that offer assessments of health risks based on people鈥檚 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鈥檚 approval.
Pathway seems to have come to the FDA鈥檚 attention as a result of a plan to sell its test over the counter at pharmacies, which is now on hold. But the agency鈥檚 move will affect other companies too. 鈥淭his policy does apply to companies selling similar tests, whether online or in physical stores,鈥� says FDA spokesman Dick Thompson.
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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 鈥渋nformational service鈥�, not a medical test. , based in nearby Foster City, is already talking to the FDA about its scans.
鈥�23andMe says its genome scan is an information service, not a medical test鈥�
