FDA Tells Google-Backed 23andMe To Stop Selling DNA Test

The Food and Drug Administration has sent a warning letter to the company 23andMe demanding that its saliva test be taken off the market. The company claims the test can detect the genetic likelihood of more than a hundred diseases — a claim the FDA says the company has not proved sufficiently.

Copyright © 2013 NPR. For personal, noncommercial use only. See Terms of Use. For other uses, prior permission required.

MELISSA BLOCK, HOST:

This is ALL THINGS CONSIDERED from NPR News. I'm Melissa Block.

AUDIE CORNISH, HOST:

And I'm Audie Cornish.

The Food and Drug Administration is cracking down on the California genetics company 23andMe. The FDA has ordered the company to stop selling tests that claim to provide people medical information by analyzing their DNA. As NPR's Rob Stein reports, the agency is concerned about the accuracy of the testing.

ROB STEIN, BYLINE: 23andMe is probably the most well-known company selling genetic tests directly to consumers. It aggressively markets its DNA tests in ads like this one.

(SOUNDBITE OF ADVERTISEMENT)

UNIDENTIFIED WOMAN #1: This is me.

UNIDENTIFIED WOMAN #2: My DNA.

UNIDENTIFIED WOMAN #3: It helps make me who I am.

STEIN: Some of 23andMe's tests are just for fun.

(SOUNDBITE OF ADVERTISEMENT)

UNIDENTIFIED WOMAN #4: It's like a self-portrait.

UNIDENTIFIED MAN #1: This part makes my eyes blue.

UNIDENTIFIED MAN #2: So that's why the sun makes me sneeze.

STEIN: No one has any problems with those tests. And the company's got lots of loyal customers who like how it champions easy access to genetic information. But 23andMe's tests claim to do a lot more than that.

(SOUNDBITE OF ADVERTISEMENT)

UNIDENTIFIED WOMAN #5: I might have an increased risk of heart disease.

UNIDENTIFIED WOMAN #6: Arthritis.

UNIDENTIFIED WOMAN #7: Gallstones.

UNIDENTIFIED MAN #3: Hemochromatosis.

STEIN: And that's where the company is running into problems. The FDA's Courtney Lias says the agency has been trying for years to get the company to prove its tests are accurate, that they're reliable, and that people understand what they mean.

COURTNEY LIAS: And they have not been able to provide that information despite us giving them ample time to do so.

STEIN: So the FDA sent 23andMe a letter, a really toughly worded letter for the FDA, telling the company that basically time's up. Stop selling those medical tests immediately until you prove to us they're safe.

LIAS: They don't have no any way of knowing whether or not their test is as accurate as they say that it is because they haven't provided the information that either we or they would need to know how accurate the test is.

STEIN: And the FDA says the are some real dangers. One test claims to tell people whether they're taking the right dose of a powerful blood thinner.

LIAS: And if that result is incorrect and they change the dose that they're taking while they're at home, then they may be at risk for stroke or even sudden death.

STEIN: Couples who find out they're supposedly carrying a genetic disease may abort a pregnancy. Women who find out they're at risk for breast cancer may get mastectomies for no good reason.

LIAS: So if people are going to rely on the results of tests like this to make important decisions like that, we need to make sure that those tests provide accurate results.

STEIN: The FDA's decision was welcomed by experts in genetics. James Evans is a geneticist at the University of North Carolina at Chapel Hill.

JAMES EVANS: I think that it's a appropriate, sober decision. It's completely in line with the best interests of public health.

STEIN: Evans says it's one thing to offer to test people to find out where their families are from, who their parents are or whether they might have certain food preferences. But when you start offering people medical advice, you have to be careful.

23andMe declined to make anyone available for an interview. In a statement, the company said it would work with the FDA to try to answer their concerns. The FDA says the company has 15 days to respond. Rob Stein, NPR News.

Copyright © 2013 NPR. All rights reserved. No quotes from the materials contained herein may be used in any media without attribution to NPR. This transcript is provided for personal, noncommercial use only, pursuant to our Terms of Use. Any other use requires NPR's prior permission. Visit our permissions page for further information.

NPR transcripts are created on a rush deadline by a contractor for NPR, and accuracy and availability may vary. This text may not be in its final form and may be updated or revised in the future. Please be aware that the authoritative record of NPR's programming is the audio.

Comments

 

Please keep your community civil. All comments must follow the NPR.org Community rules and terms of use, and will be moderated prior to posting. NPR reserves the right to use the comments we receive, in whole or in part, and to use the commenter's name and location, in any medium. See also the Terms of Use, Privacy Policy and Community FAQ.

Support comes from: