Search Results for 23andme

23andMe’s FDA coup hazardous to personal DNA data security?

[grow_thumb image=”https://telecareaware.com/wp-content/uploads/2015/03/DNA-do-not-access.jpg” thumb_width=”150″ /]Genetic test developer 23andMe’s wins with the FDA [TTA 20 Feb] served to clear the path for their current Bloom Syndrome and future kits as Class II devices. It’s long been believed that the company’s real diamond mine is in selling the DNA data gained through the kits, and with consent, to major pharma and medical companies. Proof: recent collaboration announcements with Genentech and Pfizer on genetic research. But how will this data be safeguarded? It may not be a significant concern now, but “Personal DNA information will become far more critical and more important to safeguard... Continue Reading

23andMe finally gets a nod from FDA

Breaking news: Foot in door? Crack in the wall? This week’s Big News among the genomics enthusiasts among the healthdigerati is that 23andMe finally got one test through FDA, for Bloom Syndrome where the gene is carried by both parents, and now can freely sell the kits. Much is being made of wording in the press release from a major FDA executive as opening the door: “The FDA believes that in many circumstances it is not necessary for consumers to go through a licensed practitioner to have direct access to their personal genetic information. Today’s authorization and accompanying classification, along... Continue Reading

Looking back over Telehealth & Telecare Aware’s predictions for 2014, part II

...a device-agnostic system developed by another company. Last but not least, in a pivot worthy of Nureyev in his prime, 23andme, which made much of bringing genomics testing power to the people (800,000 to date) and only secondarily using the data for medical research, but got waylaid by FDA over those pesky device clearances, is selling the data big time to Big Pharma as predicted: Genentech is investing between $10 and $50 million to use that rich data (by consent). It will be one of several pharma companies to partner extensively with Ms Wojcicki and take some investor pressure off... Continue Reading

2014: a few quotes

...dollars to spare, buy a scale, stand on it, and act accordingly. Three months later, Anne Wojcicki, the founder of 23andme – one of the genetic testing organisations mentioned in the last clip – was quoted in this Medcity News piece as saying: One doctor told me, ‘The problem with your company is that you generate too many non-billable questions”. Getting closer to home, Dr Martin McShane, NHS England Director for long-term conditions, was quoted in a piece about modernisation of the NHS in the Independent as saying: I think this is a really exciting time…the problem is we’re almost... Continue Reading

Funding, granting and executive moves

Summer hasn’t been beach holiday time for some of the companies we’ve been following….Genetic testing for the masses 23andMe, only last fall in much hot water with FDA (but recently making nice–TTA 2 July), received a two-year, $1.4 million grant from the National Institutes for Health (NIH). iHealthBeat….’Smart pill’ developer Proteus Digital Health received a Series G round of $52 million, adding to a June round of $120 million. Investors not disclosed, but Proteus currently has a blue-chip list including Novartis, Medtronic and Kaiser. BusinessWire….Pre/post-procedure education and recovery monitoring service VOX Telehealth received another $1.1 million round of angel financing... Continue Reading

Eye feels the pain of Google’s Brin and Page

...lives. Advice straight from The Gimlet Eye: My dear boys, you’ll just have to get people’s data with that old-fashioned thing, permission. (And you’d be surprised that many would be happy to give it to you.) Or if it’s all too painful, Sergey can play with his superyacht, latest girlfriend and follow his estranged wife Anne Wojcicki’s 23andme‘s ongoing dealings with the FDA. At least she’s in the arena. Google leaders think health is ‘a painful business to be in’ (SFGate) Mobihealthnews covers their true confessions, with an interesting veer off in the final third of the article to Mr... Continue Reading

23andme and FDA: making nice?

In a reversal from the ‘¡No pasarán!’ (‘They shall not pass!’) position 23andme and its QS fans famously took back in the winter and spring [TTA 2 Apr, with prior links] vis-a-vis FDA on interpretation of genetic tests, this report from VentureBeat indicates that 23andme is holding out an olive branch. It’s not your usual cutting. It’s an application for Bloom’s Syndrome, a rare inherited genetic disorder, which FDA just accepted. Adding to it is that CEO Anne Wojcicki is a carrier of this disorder. VentureBeat’s speculation is that if successful, the Bloom’s Syndrome application would be the template for... Continue Reading

mHealth: a salmagundi of items

...states, by Wellpoint. Other mHealth-related recent items worth mentioning include: at a recent event in the middle East, Michael Morgan-Curran, global director of mobile health and diabetes at mobile operators association GSMA, said mobile health care services must be standardised so data can be shared by multiple health care facilities and professionals; one in three US doctors now recommend medical apps according to this survey; the recent Medscape interview by Eric Topol of Anne Wojcicki of 23andme fame. Though a statement of the blindingly obvious, this editor particularly liked the comment that “if you have diabetes, lots of people make... Continue Reading

Picture murky: 23andMe and the FDA

Genetic testing company 23andMe seems to be in no rush to resolve its differences with the FDA, and the digitalhealtherati a/k/a D3H (Digital Health Hypester Horde) are wondering why. In late November, 23andMe executives undoubtedly had a depressing Thanksgiving when the FDA ordered them to stop providing health reports (interpretation of genetic results) and marketing kits. Four months later, 23andMe continues to sell its kits for $99, providing only raw genetic data and ancestry reports–and according to its 31 March blog posting, will do so for the foreseeable future as they complete the regulatory review process. The blog quoted CEO... Continue Reading