Tag: FDA

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 ...

Read more

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 ...

Read more

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 ...

Read more

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 ...

Read more

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 ...

Read more

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 ...

Read more

23andMe Presents at FDA Advisory Panel Meeting on Direct-to-Consumer Genetic Tests

Editor's note: This post has been altered from the original. The slides from the presentation have been removed. 23andMe, like many others, believes that individuals have a right to access their own genetic information and that personal genetics will pave the way for significant advances in healthcare. ...

Read more

23andMe at FDA/CDRH Public Meeting on Oversight of Laboratory Developed Tests (LDTs)

The FDA/CDRH Public Meeting on Oversight of Laboratory Developed Tests (LDTs) took place yesterday and today (July 19 and 20) in Washington, DC. Webcasts of both days will be available from the FDA for the next year. 23andMe's President and Co-Founder Anne Wojcicki spoke about the promise and power of ...

Read more

Update on 23andMe and the FDA

On June 10, 2010, 23andMe received a letter from the Food and Drug administration (FDA) expressing the agency's view that our Personal Genome Service™ may be subject to FDA regulation.  We have responded to this letter and are in the process of scheduling a meeting with the agency for further discussions.  ...

Read more

FDA Adds Boxed Warning to Plavix Label to Highlight Reduced Effectiveness of the Drug In Poor Metabolizers

The U.S. Food and Drug Administration (FDA) has updated the label information for the commonly used anti-clotting medication Plavix® (clopidogrel) to stress to physicians that patients carrying certain genetic variations may not receive the full benefit from the drug. Plavix reduces the chance a harmful ...

Read more

Return to top