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.
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. Transcript provided by NPR, Copyright NPR.