I wrote about the direct-to-consumer genetic testing company 23andMe back in mid-October, posing the idea that genetic information provided by the patient could only serve to enrich EMR data. I noted, “Genetic testing seems to be about empowering patients to take more proactive roles in managing their health today in an effort to prevent what might happen to their health in the future. It would make sense to share these test results with providers who can aid in that journey.”
Two readers chimed in. One noted that, “No [current] EMR can run genetic risk models or use genetic clinical decision support, [and ] [n]one of these fit into Meaningful Use, so it will be years until the EMR have the capability needed to use genomics.”
Another pointed out that, “the price point on 23andMe was all I was waiting for, and I have my gene sequence already. Yes, there are some risks, but that argument falls into the same category as any technology or innovation – it can be used for good or bad. The value this information brings far exceeds the downsides, and is now an essential part of the data feed to my personal healthcare.”
That last comment is especially interesting in light of the well-publicized tiff going on between 23andMe and the FDA. I won’t waste your time attempting to summarize the string of events that have led 23andMe to stop marketing its products, as well as a class action lawsuit and an official petition to overrule the FDA’s decision. Instead, I’ve compiled a few articles that detail the saga as it has unfolded.
Why Genetic Testing Could Endanger Your Health / ChicagoTribune.com
The FDA Drops an Anvil on 23andMe – Now What? / Stanford.edu
Founder of 23andMe speaks on FDA concerns / USAToday.com
Can 23andMe Survive the FDA? / TheVerge.com
Class Action Lawsuit Filed Against 23andMe / Forbes.com
23andMe Shuts down health-related genetics testing to work with FDA / Gigaom.com (Updated 12/6)
As far as the connection between genetic information gathered via commercial means by patients being incorporated into EMRs, it doesn’t look like it will happen easily anytime soon. It seems there are bigger debates brewing over the scope of the FDA’s regulatory power over companies like 23andMe, what the definition of a medical device should be, and the value consumers find in these services. Do they really lead to unnecessary medical tests and procedures? Let me know your thoughts on the 23andMe saga in the comments below. You can also join me this Friday at 12 ET for the weekly #HITsm tweet chat. We’ll be touching on the impact 23andMe’s big genetics data could have on healthcare, provided they’re allowed to stay in business.