23andMe
Latest
23andMe's Anne Wojcicki envisions the future of preventative medicine
Anne Wojcicki and her genetic sequencing company 23andMe are locked in a battle with the FDA. Even though it can't report results to customers right now, Wojcicki isn't letting herself get bogged down in the present. At SXSW 2014 she laid out her vision of the future of preventative medicine -- one where affordable genome sequencing comes together with "big data." In addition to simply harvesting your genetic code, the company is doing research into how particular genes effect your susceptibility to disease or your reaction to treatments. And 23andMe isn't keeping this information locked down. It has been building APIs that allow it to share the results of its research as well as the results your genetic tests, should you wish to.
23andMe stops selling DNA health tests following FDA crackdown (updated)
If you've been mulling over getting screened by 23andMe for genetic risks like cancer, we're afraid you'll have to look elsewhere. The company has just announced that it's suspending sales of its health-related personalized DNA kits its health-related genetic tests to comply with the FDA's order, as the agency has yet to conduct tests to prove its accuracy. In a blog post on the company website, co-founder Anne Wojcicki says she's "committed to making sure that 23andMe is a trusted consumer product." For now, the company is focusing on research and ensuring those who purchased a kit before November 22nd still get their results. Folks who bought one after that date will, unfortunately, have to make do with a refund. Oh, and it's worth adding that the company will still offer paternity testing and will happily send you your raw genetic data -- there just won't be any color commentary provided alongside. Update (12/7/13): Well, it looks like 23andMe will continue selling test kits, just not returning health reports to anyone who bought after November 22nd, while the company continues its dialogue with the FDA. A spokesperson told us anyone who buys a kit can still get the firm's Personal Genome Service, which includes genetic ancestry information and raw genetic data.
FDA orders 23andMe to stop selling DNA-testing kits pending approval
For more than five years, 23andMe has sent out personalized DNA test kits, offering consumers hundreds of clinical reports on their genetic risk for everything from diabetes to prostate cancer. Its mission to educate customers about their health and ancestry appears to have been dealt a blow, however, after the US Food and Drug Administration (FDA) said the company needs its approval. It's told 23andMe to stop advertising its DNA-testing product until it gets the medical device classification it needs, which involves conducting studies of the kits to gain documented proof of their accuracy. The agency is also worried that customers might take action, or not, based on test results that may or may not be correct. 23andMe has attempted to gain clearance in the past, but hasn't done everything it needs to get the green light. Make no mistake, a run-in with the FDA is not to be taken lightly: satisfying the agency's requirements is going to be a long and expensive process. 23andMe now has to tell the agency exactly how it intends to gain marketing authorization for the device, or it could face regulatory action (which includes injunctions, seizures and hefty fines). Update: 23andMe has issued a statement on the matter, and sent a letter to its customers: 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 address their concerns.
Time names the 23andMe retail DNA test 'Invention of the Year'
Time Magazine has released its annual Best Inventions issue, and topping the list is the 23andMe retail DNA test, a kit which which offers consumers 23 clinical reports on their genetic risk for everything from Psoriasis to Prostate Cancer. It may not be as well known as last year's iPhone (or YouTube the year before that), but the $399 package might signal a significant revolution in preventative medicine... or it might bring mankind a disturbing new form of eugenics. Whatever you use it for, the process couldn't be easier: the kit comes with a tube that you spit in and mail back to the company, which in a mere 4 - 6 weeks will notify you that testing is complete. As you wait for the results to be posted online you might want to spend some time contemplating the ethical dilemmas posed by this technology.
