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Comment by bengotow | Hacker News Reader

I agree - Here's a company that built a complex software system, loaded it with "if" statements pulled from research papers, and started marketing itself as a predictor of cancer and disease. How did they do their research? What is their threshold for determining if scientific evidence is conclusive enough to merit telling the world they could have a major disease? The FDA wants to know, and so do I.

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So now, people will just export their data and third party companies will provide such interpretation and the FDA won't be able to touch them. How soon until github has an open source project to read and interpret 23andme data-dumps?

Most likely anyone providing such information would also be in a similar boat with regards to the FDA.

Sure you could be overseas providing the data but it's not like the FDA is preventing you from getting overseas treatment.

I doubt it, since those people aren't making any medical devices. Moreover, the SNPedia can be used by anyone, so an open source tool can be written and deployed as an app. I highly doubt the FDA will be able to stop that.

Trying to stop someone from analyzing their health data dump is about as useless as trying to stop bitcoin transactions. About the only thing the government can try to do is to stop the public from being able to use DNA microarrays, but how long is it going to be before a cheap, consumer grade version of such chips can be made and sold in a way that the FDA can't regulate them?

You can already do that today with downloaded SNPs [1] with Promethease [2].

1. https://www.23andme.com/you/download/

2. http://www.snpedia.com/index.php/Promethease (non-pro version)

a) they never marketed themselves as predictors of cancer or told anyone they have major disease b) the criteria for scientific evidence are here https://23andme.https.internapcdn.net/res/pdf/HIC-SXIYiYqXre... (from https://www.23andme.com/for/scientists/)

Hmm - thanks for the link! Good stuff. I think the complaint I have is that in their advertising (https://www.youtube.com/watch?v=JTIY310FGBU&list=TLdNSueMINq...), they feature:

- An individual for whom 23andMe correctly identified a heart issue that he later had.

- An individual who caught his prostate cancer early because 23andMe told him he was likely to have it.

In both cases, 23andMe successfully identified the condition before it occurred. That's about as close to marketing yourself as a predictor of disease as you can get. Granted, the word for word text in the video references "elevated risk", but the overall story they're selling to the public is that 23andMe predicts diseases you'll have. At least, that's my impression. Really interested to see how all this pans out.

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