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Some interesting perspectives in this article: First, calling the FDA "a very important partner" is overly glib. The FDA is not a "partner" in the sense that
by diydsp 13y ago
Some interesting perspectives in this article:
First, calling the FDA "a very important partner" is overly glib. The FDA is not a "partner" in the sense that they will accompany you or assist you on your journey. They are only there to put the brakes on you. They are not merely "important," they are _vital_.
Second, the article is skewed to make it sound like people aren't entitled to our own DNA information. That's not what is contested. Of course, you can have access to your own DNA data, as long as the proper checks are made to ensure you're actually getting an accurate reading.
The issue is whether telling you have a disease with life-scale consequences requires validation of these claims.
There is something to be said for their tactic of giving a large number of answers instead of validating single tests, but it still requires a thorough level of validation to protect people from exploitation and it wouldn't hurt their cause to present themselves more respectfully to the authorities. Perhaps they're trying to fake casualness, that's certainly my reading, but I hope they don't screw this all up but not thinking it through and throwing around lots of bullshit.
For example, comparing themselves to Google is ludicrous. First, google's indexing search engine HAD been doing before, by altavista, webcrawler, etc., etc. Second, there was no question that whether what they were doing could negatively influence people's health and well-being. Perhaps the scholar/books scanning was a bit controversial. Perhaps some were surprised at Streetview, but that was actually legal and in both cases, they took several key measures, voluntarily, to keep themselves well inside the law. BTW, I'm no google fanboy, but to compare their IT stunts and magic tricks with potentially delivering low-quality information about life-threatening health conditions "isn't in the same ballpark. It isn't even the same goddamn sport." -Jules.
- sanxiyn 13y agoIs anyone actually contesting that 23andMe doesn't get an accurate enough reading of DNA? I thought the problem was all with interpretation. https://www.23andme.com/more/science/ https://www.23andme.com/more/science/ states "Data quality starts with the laboratory that processes your DNA. Our contracted laboratory is licensed by the federal government to perform clinical testing. It uses standardized processes and procedures that ensure highly accurate genetic data." and so far I haven't seen anyone contesting this. That is, DNA reading part is already regulated.
- diydsp 13y agoYes. The FDA is contesting that 23andMe doesn't get an accurate enough reading of DNA. FTFA: "Last week, the F.D.A. ordered 23andMe to stop marketing its genetic test because it said the company had not provided adequate evidence that the tests were accurate,"
- sanxiyn 13y ago"genetic test (of diseases)" is quite different from reading DNA, and presumably includes interpretation. I don't understand how can reading DNA part can be inadequate, given that it's the same lab doing the same process as other clinical testings. 23andMe is using off-the-shelf SNP array, it's not like it's doing anything special with respect to reading DNA.