FDA Tells Company To Stop Selling Genetic Test

The Food and Drug Administration has issued a warning letter to the company 23andMe. It wants the company to stop selling its $99 saliva test to detect a person's genetic predisposition to various diseases.

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

STEVE INSKEEP, HOST:

A high-profile genetic medical testing company is in trouble with the federal government. The Food and Drug Administration has asked 23 And Me to temporarily halt its work.

As NPR's Rob Stein reports, the FDA has accuracy concerns.

ROB STEIN, BYLINE: 23 And Me may be best known for its $99 genetic test. For $99, anyone can get their DNA analyzed. No need to go to a doctor. No need to get their blood drawn. Just send in a saliva sample and wait to find out all sorts of things: How your body handles caffeine, how certain drugs work for you, and whether you're at risk for all kinds of diseases. And that's where 23 And Me is running into trouble.

Courtney Lias of the FDA says the company has failed to do the studies that prove their medical tests are accurate.

COURTNEY LIAS: They don't have any way of knowing whether or not their test is as accurate as they say that it is because they haven't actually provided the information that either we or they would need to know how accurate the study is.

STEIN: And the FDA says that's a big problem. Customers may make major decisions based on the results. For example, women might resort to drastic measures that are unnecessary if they think they're at risk for breast cancer.

LIAS: Women who find out that they are positive may take steps like surgery or mastectomy in order to avoid breast cancer.

STEIN: So the FDA has ordered 23 And Me to stop selling its medical testing until the company proves it's reliable. The company would only say it will work with the FDA to satisfy the agency's concerns. The FDA says 23 And Me has about two weeks 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: