June 14th, 2010
02:08 PM ET

FDA warns companies selling at-home genetic tests

By Carrie Gann
CNN Medical News Intern

The FDA is warning companies that sell laboratory-to-consumer genetic testing that their products cannot be marketed without FDA approval. The agency said that it is concerned about the accuracy of the tests and that consumers may use the results to make important medical decisions.

On Friday, the FDA sent letters to five companies - 23andMe, Navigenics, DeCODE Genetics, Illumina and Knome – notifying them that they must submit their products for review or discuss with officials why their products do not require FDA approval. In its letter to 23andMe, the agency said it wants to prevent consumers from being “misled by incorrect test results or unsupported clinical interpretations.”

However, the FDA did not say that such genetic testing services should be taken off the market.

The five companies had mixed responses to the FDA’s warning. 23andMe said Friday that the company disagreed with the FDA’s decision, while representatives for Knome said that the company welcomed the FDA’s review.

The FDA’s warnings come almost one month after Walgreen drugstores halted plans to sell DNA testing kits after the kits’ manufacturers, Pathway Genomics, received a similar letter from the FDA. More recently, officials were concerned when 23andMe reported a laboratory mistake had caused up to 96 of its customers to receive genetic test results about someone else.

More information on the benefits and drawbacks of direct-to-consumer genetic tests can be found here.

Editor's Note: Medical news is a popular but sensitive subject rooted in science. We receive many comments on this blog each day; not all are posted. Our hope is that much will be learned from the sharing of useful information and personal experiences based on the medical and health topics of the blog. We encourage you to focus your comments on those medical and health topics and we appreciate your input. Thank you for your participation.

soundoff (142 Responses)
  1. FtghEncox

    good conclusions for research papers cpm homework help online writing a three paragraph essay

    December 1, 2020 at 23:30 | Report abuse | Reply
  2. FgsZisse

    essay writing volunteers in baltimore custom paper writing service media essay

    December 2, 2020 at 05:08 | Report abuse | Reply
  3. FnrdEncox

    viagra mexico walmart generic viagra soft tabs delhi, india viagra

    December 3, 2020 at 00:00 | Report abuse | Reply
  4. FnsbEncox

    order essays writing your college essay in third person assignment helper

    December 3, 2020 at 04:22 | Report abuse | Reply
  5. FqfEncox

    worst college essays essay king the thesis statement in a research essay should

    December 3, 2020 at 07:11 | Report abuse | Reply
  6. FnrhEncox

    viagra india website inurl:forum newsletter viagra cheap viagra in the usa

    December 4, 2020 at 09:58 | Report abuse | Reply
  7. DvncZisse

    cialis & viagra buy cialis no prescription prices on cialis

    December 8, 2020 at 11:25 | Report abuse | Reply
  8. KhedMile

    cialis paypal viagra cheaper viagra pills viagra in the usa overnight delivery

    December 9, 2020 at 20:27 | Report abuse | Reply
  9. detectives privados formentera

    Detectives privados san Sebastián de los reyes


    December 10, 2020 at 08:43 | Report abuse | Reply
  10. JgsvCrulk

    is viagra from canada safe? viagra on sale viagra usa rezeptfrei

    December 10, 2020 at 21:19 | Report abuse | Reply
  11. FsfgEncox

    viagra on line pay pall australia 300 mg viagra buy viagra in spain

    December 11, 2020 at 18:59 | Report abuse | Reply
  12. FgnsZisse

    how to buy cialis in sydney buy cialis online cialis australia

    December 11, 2020 at 22:01 | Report abuse | Reply
  13. FbsbEncox

    cialis black buy in australia cialis online safe cialis rush

    December 12, 2020 at 08:39 | Report abuse | Reply
  14. FgrsEncox

    how much costs viagra in india viagra south africa online generic viagra sales

    December 13, 2020 at 04:52 | Report abuse | Reply
  15. DvnjZisse

    viagra for sela what are the different types of viagra viagra discount

    December 13, 2020 at 09:10 | Report abuse | Reply
  16. FqbfEncox

    brand name cialis online which is safer viagra or cialis cheap generic cialis

    December 13, 2020 at 12:46 | Report abuse | Reply
  17. bitcoin to paypal

    Transfer from bitcoin to paypal very fast and low cost.


    December 15, 2020 at 19:31 | Report abuse | Reply
  18. FhsnZisse

    buy viagra germany viagra syd 100 mg pfizer viagra no prescription

    December 16, 2020 at 21:05 | Report abuse | Reply
  19. Boyce Bruni

    some really nice and utilitarian info on this web site, likewise I believe the layout has got fantastic features.


    December 31, 2020 at 22:14 | Report abuse | Reply
  20. Darnell Decourcey

    I like this web site very much, Its a rattling nice place to read and receive info .


    January 4, 2021 at 06:09 | Report abuse | Reply
  21. FwsxEncox

    treatment for erectile dysfunction medicine for erectile discount rx

    January 10, 2021 at 10:57 | Report abuse | Reply
  22. JtmfEncox

    erectile dysfunction causes erectile dysfunction drug pharmacy today

    January 10, 2021 at 17:26 | Report abuse | Reply
  23. FgvdZisse

    rx pharmacy online drugstore near me pharmacy rx one

    January 10, 2021 at 22:26 | Report abuse | Reply
  24. KhthMile

    canada pharmacy reviews canadian pharmacy pharma

    January 12, 2021 at 01:55 | Report abuse | Reply
  25. JlloCrulk

    uk pharmacy best drugstore shampoo ed meds

    January 12, 2021 at 22:12 | Report abuse | Reply
  26. LokuEncox

    canadian drug pharmacy rx express pharmacy pharmacy rx

    January 12, 2021 at 22:30 | Report abuse | Reply
  27. FgnhZisse

    best alternative to viagra best price viagra no presription buy generic viagra using mastercard viagra for canada nitric oxide and viagra can i buy viagra without a prescription viagra spain chep viagra viagrarx generic viagra in canada viagra for sale onlkne viagra super active viagra replacement viagra in budapest viagra discount

    January 15, 2021 at 02:07 | Report abuse | Reply
  28. JvcxCrulk

    viagra with dapoxetine viagra for sale in the uk when viagra patent run out usa viagra generic viagra online mastercard authentic viagra can i order viagra online without prescription cheap viagra and cialis in australia viagra and dapoxetine viagra no pascription viagrasuperforte viagra windsor canada buy online viagra in melbourne australia reliable pharmacy online for viagra vid shop viagra

    January 16, 2021 at 22:11 | Report abuse | Reply
  29. KlioMile

    canadian generic viagra viagra without rx generic viagra viagra natural china cheapviagra can you buy viagra over the counter in uk free viagra online in canada viagra canada no prescription viagra off patent date generac viagra canadian generic viagra generuc viagra viagra professional buy brand viagra australia viagra india online

    January 17, 2021 at 02:45 | Report abuse | Reply
  30. NlbxZisse

    bay viagra on line how to buy viagra in shanghai super viagra uk viagra throught paypall buy viagra with echeck looking to purchase generic viagra i want buy viagra in mumbai wats rate wo is shop online viagra greece where can i buy viagra in sydney viagra act viagra vs cialis side effects viagra buy online canada viagra online canada viagra and sports performance viagra online order

    January 18, 2021 at 03:02 | Report abuse | Reply
  31. FbdhZisse

    cialis indien bezahlung mit paypal generic cialis vs cialis cialis blog http://21cialismen.com/ – germany cialis professional ’

    January 20, 2021 at 02:35 | Report abuse | Reply
  32. JbdcEncox

    how i can buy viagra without prescription in chicago where can i get viagra cheap chewable viagra soft tabs http://llviabest.com/ – best price on generic viagra ? ’

    January 20, 2021 at 12:05 | Report abuse | Reply
  33. AqbvEncox

    ingredient in viagra viagra prescription austin online cheapest viagra with mastercard http://acialaarx.com/ – buy viagra no prescription by cipro ’

    January 21, 2021 at 17:33 | Report abuse | Reply
  34. JvcbxCrulk

    cheap cialis by post generic cialis soft tabs buy cialis 36 hour online http://phrcialiled.com/ – viagra vs cialis ’

    January 21, 2021 at 19:25 | Report abuse | Reply
  35. KbctMile

    how to buy cialis online cialis dosage local generic cialis in united states http://mycialedst.com/ – cialis with dapoxetine ’

    January 21, 2021 at 23:02 | Report abuse | Reply
  36. LcxEncox

    can yu buy viagra over the counter at chemist in australia viagra pay buying viagra online http://genqpviag.com/ – buy viagra in nyc ’

    January 22, 2021 at 14:08 | Report abuse | Reply
  37. NlbxZisse

    generic cialis for sale buy cialis asap cialis dapoxetine http://cialijomen.com/ – cheap cialis canadian ’

    January 23, 2021 at 02:54 | Report abuse | Reply
  38. FbgZisse

    buy viagra online buying viagra in uk viagra online au https://canadianpharmacy-usx.com/organic.htm – viagra soft tabs uk ’

    January 24, 2021 at 22:01 | Report abuse | Reply
  39. FmfvEncox

    buy cialis online with check black cialis from singapore price of cialis at walmart http://sjcialis.com/ – best price on generic cialis ’

    January 25, 2021 at 00:16 | Report abuse | Reply
  40. JnhCrulk

    online cialis does cialis work find cialis online http://loncialis.com/ – cialis super active ’

    January 26, 2021 at 03:31 | Report abuse | Reply
  41. KbbtMile

    generic cialis 7days Glucophage cialis on line https://xz-pharmacyonline.com – cheap viagra online canadian pharmacy ’

    January 26, 2021 at 07:11 | Report abuse | Reply
  42. AhmdEncox

    generic cialisw cialis in las vegas best prices for generic cialis http://cialmenshoprx.com/ – cialis tadalafil 20mg ’

    January 26, 2021 at 11:53 | Report abuse | Reply
1 2 3

Post a comment


CNN welcomes a lively and courteous discussion as long as you follow the Rules of Conduct set forth in our Terms of Service. Comments are not pre-screened before they post. You agree that anything you post may be used, along with your name and profile picture, in accordance with our Privacy Policy and the license you have granted pursuant to our Terms of Service.

About this blog

Get a behind-the-scenes look at the latest stories from CNN Chief Medical Correspondent, Dr. Sanjay Gupta, Senior Medical Correspondent Elizabeth Cohen and the CNN Medical Unit producers. They'll share news and views on health and medical trends - info that will help you take better care of yourself and the people you love.