After FDA Objections, 23andMe Won't Offer Health Information 146
sciencehabit writes "The company 23andMe will no longer provide health information to people who purchase its DNA testing kit, it announced last night.The change was 'to comply with the U.S. Food and Drug Administration's directive to discontinue new consumer access during our regulatory review process,' the statement said. While current customers will still have access to a 23andMe online database noting the health issues associated with their particular DNA, the company will not update that information, and customers who purchased its Personal Genome Service (PGS) on or after 22 November will receive only information about their ancestry and their raw genetic data without interpretation." It would be great to see a secondary market in this kind of analysis emerge.
There already is a secondary market already (Score:5, Informative)
From snpedia.com [snpedia.com]:
Re:smart (Score:4, Informative)
There is a secondary market. Most large hospitals have genetic counselors who are trained and qualified to interpret and present the results of genetic testing.
Re:smart (Score:5, Informative)
Those are the results of individual FDA approved genetic tests.
A "secondary market" for running thousands of tests at once would run into the same problem that 23andMe did: if you are going to sell diagnostic services in the USA then you will need to get FDA approval. The options are to only provide raw data and let someone else generate the report for free (see Promethease, mentioned below) or move the whole company someplace where law enforcement won't bother it. I could see 23andMe spinning off an independent foundation that would generate free reports, thus allowing their core business (building up a database of peoples DNA and personal/family medical histories that they can rent out for medical research free from the normal regulatory hurdles) to proceed unhindered. They would just have to be very careful to make certain there was no linkage between the for profit and the free companies: the non-profit would have to generate reports from data of any source, not just SNPs from 23andMe, it couldn't share any board members or employees with 23andMe, Google, etc.
Next legal challenge for 23andMe: doing medical research on people (gathering their DNA and medical histories, analyzing, allowing 3rd parties to analyze, etc) without getting IRB approvals first.
From a 2010 Cell paper (Score:5, Informative)
http://www.ncbi.nlm.nih.gov/pubmed/20828856 [nih.gov]
Thord party analysis (Score:5, Informative)
> It would be great to see a secondary market
> in this kind of analysis emerge.
There are already companies (livewello.com, for instance) that will take your 23andme raw data and analyze it for certain traits and risk factors.
Re:good riddance (Score:4, Informative)
What 23andMe does is market a product that you use to extract unique information about your own body, which is then presented to you in the form of suggestions about what health measures you should take -- in other words, medical advice. Very different.
Whoa, what? They have never been in the business of medical advice! What they did is to say, "you have genetic marker X which according to studies A and B are indicative of a 20% increased susceptibility to disease Y or and 50% increased likelihood to have an adverse reaction to drug Z." That is not medical advice! That is mere information, filtered by your genetic markers.
Re:smart (Score:5, Informative)
That quote isn't quite complete. They've only discontinued new user access to health related tests. They're still providing ancestry information.
The majority of the really useful information is genetic. The health information was secondary. Really, the whole health thing was vague at best, and it didn't take a rocket scientist to figure it out.
For example, gallstones. My risk is 6.2%, where avg risk is 7.0%. Not bad, I have a lower chance.
I had to have my gallbladder removed a year ago, because I had two golf ball size stones. Yup, anything greater than a 0.0% chance means there is a chance. Lucky me.
Anyways, here's the full email they just sent out to 23andMe customers today.