The U.S. Food and Drug Administration is telling a company that sells cheap DNA testing to stop for now.
The company, 23andMe, is a startup that can analyze your DNA (by collecting your spit) for $99. The test is marketed as a way to trace your lineage, find relatives, and look into hereditary risk for more than 240 health conditions.
Nearly half a million people have taken 23andMe’s test in the past five years, The New York Times says.
But no more, at least for now. Last Friday, the FDA sent founder Anne Wojcicki “an unusually stern letter” warning her to end sales and marketing of the DNA test immediately, The Wall Street Journal says, after it noticed the company had begun new marketing campaigns, including TV commercials.
The letter can be read in full on the FDA website, but it basically says the FDA isn’t satisfied the test works sufficiently well, and that mistakes could be dangerous to consumers. It says, in part:
If the BRCA-related risk assessment for breast or ovarian cancer reports a false positive, it could lead a patient to undergo prophylactic surgery, chemoprevention, intensive screening, or other morbidity-inducing actions, while a false negative could result in a failure to recognize an actual risk that may exist. …
We have become aware that you have initiated new marketing campaigns, including television commercials that, together with an increasing list of indications, show that you plan to expand the [testing service’s] uses and consumer base without obtaining marketing authorization from FDA.
The company and the FDA have gone back and forth for several months, MarketWatch says, and the FDA is frustrated at 23andMe’s pace in conducting the research necessary to get its approval.
“Months after you submitted your 510(k)s [clearance forms] and more than five years after you began marketing, you still had not completed some of the studies and had not even started other studies necessary to support a marketing submission,” the FDA wrote. “It is now eleven months later, and you have yet to provide FDA with any new information about these tests.”
Some say there’s no good reason to target the company. Other companies, including deCODE Genetics, Illumina, Navigenics and Knome, also sell DNA tests, MarketWatch says. But only 23andMe, whose investors include Google and Johnson & Johnson, got a letter.
“The FDA is targeting a startup that already takes steps to accurately present results,” Bloomberg Businessweek’s Diane Brady says. “The 23andMe test offers a simple promise on the health front: clarity on your genetic makeup, linked to peer-reviewed research on correlated health risks or benefits.”
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