23andMe Halts Health-Related Genetic Test Sales

Ancestry information and raw data will still be available, as the company undergoes FDA review.

National Journal
Sophie Novack
See more stories about...
Sophie Novack
Dec. 6, 2013, 5:31 a.m.

Dir­ect-to-con­sumer ge­net­ic test­ing com­pany 23andMe will stop sales of health-re­lated tests fol­low­ing a warn­ing let­ter from the Food and Drug Ad­min­is­tra­tion two weeks ago.

“23andMe has been giv­ing con­sumers ac­cess to health in­form­a­tion for six years and is com­mit­ted to find­ing the right reg­u­lat­ory path for our cus­tom­ers,” CEO and founder Anne Wo­j­cicki wrote in a state­ment on the com­pany web­site Thursday. “I am highly dis­ap­poin­ted that we have reached this point and will work hard to make sure con­sumers have dir­ect ac­cess to health in­form­a­tion in the near fu­ture. Our goal is to work co­oper­at­ively with the FDA to provide that op­por­tun­ity.”

The goal of 23andMe is to provide con­sumers with dir­ect ac­cess to their ge­net­ic in­form­a­tion in an easy and af­ford­able way. A test can be pur­chased on­line for $99, and provides re­ports on 254 dif­fer­ent con­di­tions and dis­eases.

However, the FDA ex­pressed con­cerns that the com­pany was selling its product as a dia­gnost­ic test for health risks. The agency said 23andMe must gain gov­ern­ment au­thor­iz­a­tion be­fore con­tinu­ing to mar­ket the product as a med­ic­al test.

The com­pany will con­tin­ue to provide an­ces­try in­form­a­tion and raw data to con­sumers, but will put the sale of health-re­lated res­ults on hold.

In­di­vidu­als who pur­chased ge­net­ic test­ing kits pri­or to when the FDA let­ter was sent on Nov. 22 will con­tin­ue to have ac­cess to their full res­ults. Those who pur­chased them on or after that date will only re­ceive an­ces­try in­form­a­tion and raw data, and will be eli­gible for a re­fund.

Wo­j­cicki em­phas­ized that the com­pany stands by their data, not­ing that the samples are sent to CLIA cer­ti­fied labs — the same stand­ards used for most health-re­lated tests.

“The in­form­a­tion 23andMe provides is in­cred­ibly ac­cur­ate,” 23andMe spokes­wo­man Cath­er­ine Afar­i­an told Na­tion­al Journ­al in early Novem­ber. “If we tell you you’re a C-C there, you are. From there, the next step is in­ter­pret­a­tion — what does sci­ence know about it?”

This is where the res­ults be­come less clear. 

As Na­tion­al Journ­al pre­vi­ously re­por­ted, there is a sig­ni­fic­ant amount of un­cer­tainty re­gard­ing the in­ter­pret­a­tion side of these test res­ults. The con­cern is that in­di­vidu­als may make im­port­ant med­ic­al de­cisions based on res­ults that are con­stantly chan­ging and that even ex­perts don’t com­pletely un­der­stand.

The com­pany will con­tin­ue to move for­ward with the FDA’s reg­u­lat­ory re­view pro­cess, and hopes to re­sume of­fer­ing health-re­lated in­form­a­tion shortly.

What We're Following See More »
STAFF PICKS
What the Current Crop of Candidates Could Learn from JFK
21 hours ago
WHY WE CARE

Much has been made of David Brooks’s recent New York Times column, in which confesses to missing already the civility and humanity of Barack Obama, compared to who might take his place. In NewYorker.com, Jeffrey Frank reminds us how critical such attributes are to foreign policy. “It’s hard to imagine Kennedy so casually referring to the leader of Russia as a gangster or a thug. For that matter, it’s hard to imagine any president comparing the Russian leader to Hitler [as] Hillary Clinton did at a private fund-raiser. … Kennedy, who always worried that miscalculation could lead to war, paid close attention to the language of diplomacy.”

Source:
STAFF PICKS
Maher Weighs in on Bernie, Trump and Palin
22 hours ago
WHY WE CARE

“We haven’t seen a true leftist since FDR, so many millions are coming out of the woodwork to vote for Bernie Sanders; he is the Occupy movement now come to life in the political arena.” So says Bill Maher in his Hollywood Reporter cover story (more a stream-of-consciousness riff than an essay, actually). Conservative states may never vote for a socialist in the general election, but “this stuff has never been on the table, and these voters have never been activated.” Maher saves most of his bile for Donald Trump and Sarah Palin, writing that by nominating Palin as vice president “John McCain is the one who opened the Book of the Dead and let the monsters out.” And Trump is picking up where Palin left off.

Source:
×