The Food and Drug Administration has ordered Google-backed genetic test maker 23andMe to
halt sales of its personalized DNA test kits, saying the company has failed to show that
the technology is supported by science.
In a warning letter posted online Monday, FDA regulators say that the Silicon Valley has
not shown that its tests are safe or effective despite "more than 14 face-to-face and
teleconference meetings" and "hundreds of email exchanges." The agency
orders 23andMe to stop marketing its test immediately, warning that erroneous results
could cause customers to seek unnecessary or ineffective medical care.
23andMe's saliva-based test kit, launched more than 5 years ago, claims to tell
customers if they are at risk for more than 250 diseases and health conditions. The FDA
says only medical tests that have been cleared by the government are permitted to make
Jim in Charlotte