Published on November 30th, 2013 | by No Artificial
FDA Warns 23andMe
Food and Drug Administration ordered genetic test maker 23andMe to halt sales of its personalized DNA test kits.
In a warning letter posted online, FDA regulators say the 23andMe company is violating federal law because its $99 Saliva Collection Kit and Personal Genome Service (PGS) claim to identify health risks for more than 250 diseases and health conditions.
Already, over 500,000 people have used 23andMe’s DNA analysis kits to learn more about their ancestry, health risks, and genetic predisposition to a wide variety of factors.
The FDA says “some of the uses for which PGS is intended are particularly concerning, because the tests could have life-altering health consequences “that could result from false positive or false negative assessments for high-risk indications.”
In response, 23andMe released a statement saying, “We recognize that we have not met the FDA’s expectations regarding timeline and communication regarding our submission. Our relationship with the FDA is extremely important to us and we are committed to fully engaging with them to address their concerns.”
The company’s Co-founder and CEO Anne Wojcicki has also sent a letter to her customers further explaining their position relative to the FDA’s order:
“It is absolutely critical that our consumers get high quality genetic data that they can trust. We have worked extensively with our lab partner to make sure that the results we return are accurate. We stand behind the data that we return to customers – but we recognize that the FDA needs to be convinced of the quality of our data as well.
“I am committed to providing each of you with a trusted consumer product rooted in high quality data that adheres to the best scientific standards. All of us at 23andMe believe that genetic information can lead to healthier lives.”
Many people have criticized the FDA over this ban. They believe that in a free society, patients have a right to accurate data about their health, even if medical professionals and regulators fear patients will misuse it. That consists of information about the genetic code.
Resource: CBS NEWS