Tag: FDA

An Update Regarding The FDA’s Letter to 23andMe

23andMe was started in 2007 with the belief that consumers have the right to get access to their genetic information and that information can help them live healthier lives. It is absolutely critical that our consumers get high quality genetic data that they can trust.   We have worked extensively with our ...

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23andMe Statement Regarding FDA Warning Letter

We have received the warning letter from the Food and Drug Administration. 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 ...

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New Standards Regulating Gluten Labeling

New rules issued by the US Food and Drug Administration earlier this month mean we may finally know what it means when a label on food we buy says “Gluten-Free.” The new standards are hugely important for the more than 3 million Americans with celiac disease as well as many others who for other reasons may ...

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Blood Thinners and the Genetics Behind Drug Response

A study in the journal Lancet regarding a new blood thinning drug brings to mind the difficulty doctors and patients have in using anticoagulants to prevent clots that could otherwise lead to heart attacks or strokes. The mostly commonly used blood thinner, warfarin (Coumadin®) has proven to be a godsend ...

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23andMe Takes First Step Toward FDA Clearance

Today 23andMe announced that we’ve submitted our first round of 510(k) documentation to the U.S. Food and Drug Administration (FDA). The application provides a detailed description of our Personal Genome Service®, extensive data supporting the performance of our technology, and comprehensive discussions of ...

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Hope in a Pill: New Treatment for Cystic Fibrosis Approved

The realization of a long-awaited hope arrived this past month for many families in the form of a new treatment for cystic fibrosis. Cystic fibrosis (CF) is one of the most common recessively inherited diseases, affecting about 30,000 people in the United States. There are at least 500 mutations in a gene ...

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The Debate Over Clopidogrel Continues

In December a new study created quite a stir in the already-volatile clopidogrel research community. Clopidogrel (trade names Plavix®) is a commonly prescribed anti-clotting drug. It is inactive in the body until a protein encoded by the gene CYP2C19 converts the drug to its active form. Some people are able ...

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FDA to Hold Public Town Hall Discussion in San Francisco

In March earlier this year, 23andMe presented its views on possible federal regulation of the direct-to-consumer (DTC) genetic testing industry at an Advisory Committee meeting convened by the FDA. We reiterated our belief that individuals have a right to access their own genetic information without physician ...

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Public Comments Due on Possible FDA Regulation of Direct to Consumer Genetic Testing

From its founding 23andMe has made clear its views that people should have a right to access their own genetic information. And in the debate over regulation of direct to consumer genetic testing, we’ve made our views clear to officials at the Federal Drug Administration (FDA). Have you? May 2nd ...

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DTC Genetic Tests and the Future of Regulation: Make Your Voices Heard

On March 8th, the FDA convened a two-day advisory panel meeting to discuss questions related to direct-to-consumer genetic tests. The questions focused on the benefits and risks of providing consumers with direct access to these tests, potential strategies for communication and education to mitigate any ...

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