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
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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.

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