Electronic health records are supposed to play a pivotal role in the Obama administrations Precision Medicine Initiative which hopes to collect data from a million or more volunteers, serving as part of a national research cohort. But, according to Anne Wojcicki, CEO of direct-to-consumer genetic testing company 23andMe, self-reported data has more value than EHRs.
We all talk about EHRs as the gold standard. But we overwhelmingly love self-report data, Wojcicki told an April 29 workshop held by the National Institutes of Healths Precision Medicine Initiative Working Group, formed to help develop the national research cohort of participants. If anything, EHRs are an incredible amount of work to clean up. Weve done head-to-head studies on EHRs versus self-reported data and its a lot of work.
EHRs are great for the drug history and are great for the labs, but she insisted that the self-report data actually works much better than what anyone anticipates.
Under the $215 million Precision Medicine Initiative, a national research cohort of 1 million or more participants will volunteer to share their biological, environmental, lifestyle and behavioral information, as well as tissue samples with researchers. NIH is taking a lead role in the multi-agency effort which also includes the Food and Drug Administration and the Office of the National Coordinator for Health Information Technology.
23andMe, based in Mountain View, Calif., has more than 950,000 customers worldwide with over 80 percent who have consented to participate in what Wojcicki calls very broad and essentially unlimited research. To date, more than 250 million phenotypic data points have been collected, she revealed, which 23andMe is able to share anonymously pooled data about self-reported health traits.
We have actually been doing research since 2009, said Wojcicki. We put out questionnaires to our customers as a self-report format. She informed the Precision Medicine Initiative Working Group that in one case 23andMe sent one quick question to our customers and in 60 hours we collected over 5 million phenotypic data points, adding that this illustrates how much people want their genomes; people want their genetic information.
In February 2015, the FDA authorized for marketing 23andMes Bloom Syndrome carrier test, a direct-to-consumer genetic test to determine whether a healthy person has a variant in a gene that could lead to their offspring inheriting this rare but serious disorder that carries with it a greatly increased risk of cancer.
However, when it comes to regulatory matters, it hasnt been all smooth sailing for the company. 23andMe had previously marketed a personal genome service in the U.S. but it ceased providing direct health information to consumers after the FDA issued a 2013 warning letter, directing the company to stop selling the product because of failure to obtain marketing clearance or approval to assure their tests were accurate, reliable and clinically meaningful.
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