Less than a year since the US Food and Drug Administration ordered 23andMe, the leading personalized genetic testing company to cease and desist in DNA testing without the proper medical protocols, the National Institute of Health (“NIH”) has awarded the company a $1,367,504 for a two-year project to support the further development of 23andMe’s web-based database and research engine for genetic discovery.
“A huge advancement for affordable Personalized Medicine that will increase accessibility and improve health outcomes”
James P. McNamara
As you will recall, in November 2013 the FDA told 23andMe to stop testing and issuing results to individuals because the results could mislead customers, who did not have a medical training to understand the full scope of the findings. The FDA said the startup–which uses consumer’s saliva to provide information on gene mutations, health risks and drug responses–did not submit adequate data to support its claims and had continued to sell unapproved, unverified service for years, FierceHealthcare previously reported.
Because of the FDA ruling, the company provides ancestry-related genetic reports and uninterpreted raw genetic data. It no longer offers its “health-related genetic reports,” according to an alert on its website.
With the new NIH funding, the company said it will use the genetic data it has collected for a range of research projects. Specifically, the grant supports four areas of development:
1) Refinement of web-based surveys to improve the company’s ability to identify novel genetic associations;
2) Enhanced infrastructure of survey tools to support the collection of a broader set of phenotypic data;
3) The utilization of whole-genome sequencing data and imputation to enable the discovery of rarer, more penetrant genetic associations; and,
4) Enablement of external non-23andMe researchers to access aggregate de-identified data from the 23andMe database to further accelerate the pace of human genetic research.
The grant “enables researchers from around the world to make genetic discoveries,” Anne Wojcicki, chief executive officer of 23andMe, said in a statement. Despite the challenges the company has been faced with, it has not shied away from discussions with the governments on the need for merging technology, health databases and patient control to improve health outcomes for all.
“The is a huge development in the acceleration of affordable Personalized Medicine and the so-called P4 Medicine Model of Personalization, Prediction, Prevention and Participation” said James P. McNamara, a Health Futurist. “The grant will also support the development of a Research Accelerator that will create new opportunities for global research collaborations between academia and the biosciences industry with the goal of improving health outcomes.”
“For the first time, technology and healthcare are coming together and consumers want to be part of it,” Wojcicki said at a recent panel held by the House Energy and Commerce Committee as part of its 21st Century Cures initiative.
Meanwhile, 23andMe also is working to get back in the FDA’s good graces–it is trying to push through a single health report on Bloom syndrome through the approval process for medical devices, according to a recent article in MIT Technology Review.
To learn more: 23andMe Press Release