The personal genome company 23andMe has launched a new platform that will allow researchers to see and track certain genetic information from patients in their clinical trials.
The Californian company, run by Anne Wojcicki, was originally set up to allow consumers for a $99 fee to be able to spit into a tube, have this sent off and then have the company send them back an analysis of what their genes hold, and whether this showed up higher risks of certain diseases or conditions.
But the FDA back in 2013 took exception to this--with concerns over accuracy and a potential increase in patients seeking unnecessary ops and procedures by misreading their genetic info.
The regulator thus banned the sale of its consumer-based service, restricting it to offering ancestry data for consumers to identify DNA relatives and explore their heritage.
In the past year, after talks with the FDA, 23andMe has sought to slowly bring some of its original services back, but has relied heavily on biopharma deals to keep the money coming in. Now, it is extending this service into clinical trials.
In a nutshell, this new deal will allow researchers (with an IRB-approved study) to collect genetic information directly from patients enrolled in clinical trials, and will also use mobile tech to help store the data.
Under the platform, researchers will be able to use 23andMe to both track and manage their trial projects.
They can also download data in real time as samples are genotyped through a new service called the "23andMe Researcher Dashboard." This can then be paired with 23andMe's mobile API for ResearchKit--an open source framework for medical research from Apple ($AAPL).
Scientists will then be able to create apps to collect digital phenotypes on smartphones to study alongside genetic information.
And what’s more, if patients give their consent, then an anonymous, aggregated form of all of their genetic data can be sold by 23andMe to other researchers--and pharma companies--for other research purposes.
Patients, too, will also be able to see the same genetic information that their researchers are seeing--a quid pro quo from 23andMe in exchange for their participation.
23andMe is essentially setting itself up as a one-stop-shop for the often challenging situation of managing DNA collections. The company said it will handle the whole collection, processing and storage of the DNA samples, in what it says will save researchers time.
"The 23andMe GSR platform simplifies the genotyping process and allows any researcher with an IRB-approved study to incorporate genetics into their research, regardless of their own genetics expertise," said Ruby Gadelrab, 23andMe's vice president of commercial marketing.
"Typically, research studies don't return any data to the participants. We've enabled researchers to give results back to participants in the form of the 23andMe experience, which we believe is a huge advantage in recruiting. This is the way research studies of the future will be conducted, as evidenced by the desire of those leading the Precision Medicine Initiative to return results to participants."
Last year, 23andMe had a genotyped population of over 800,000 individuals--with more than 80% having consented to participate in research.
This follows on from a number of research deals 23andMe has penned in the past two years, including a Parkinson’s disease R&D collab with Roche’s ($RHHBY) biologics arm Genentech in early 2015--followed closely by a deal with Pfizer ($PFE) for it to have access to its research and analysis services, and a few months later, it also signed a lupus study deal with the company.
23andMe has raised about $241 million in venture capital, but has not disclosed the financial details of the above deals.
- check out the release
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