Following up on the rumours I posted about yesterday regarding a potential bid by the FDA to choke of direct-to-consumer genetic testing companies' supply of genotyping chips, I received the following statement by email from 23andMe's PR firm:
23andMe is engaged in an ongoing process with the FDA.
23andMe understands that Illumina is also engaged in such a process.
23andMe has no reason to believe there will be an interruption in the supply of Illumina chips at this time.
I understand we'll have some more clarity on this issue from the FDA tomorrow.
More like this
Steve Murphy is up in arms about a recent email from 23andMe to its customers advertising the use of genetic variants on its V2 chip to predict individual risk of statin-induced myopathy and breast
A tweet from personal genomics company 23andMe (see screenshot below) sparked my interest:
It's been an intensive week of genomics here at the American Society of Human Genetics meeting, and I haven't been able to grab time to blog as much as I'd have liked.
I'm hearing about rumblings at 23andMe, and not in a good way. The company made a big splash a few years ago, and came highly recommended by friends (e.g., "They know their science, and have a bottomless pool of money").
I guess the FDA don't do clarity. This story does not look like it is over yet, see Mary Carmichael
www.newsweek.com/2010/08/05/dna-dilemma-day-four-should-genetic-tests-b…
http://www.newsweek.com/blogs/the-human-condition/2010/08/05/dna-dilemm…
What the heck? The FDA doesn't take costs into account? Huh?
How are we supposed to control costs in healthcare then?
If this is an 'agency wide' policy this is a serious issue and much bigger than DTC.
Their clarification is also clear as mud
So...they are relying on a creative interpretation of the law which allows them to vastly expand their authority to cover thousands upon thousands of clinical labs without actually going through any kind of formal rulemaking process, or doing even the most BASIC evaluation of costs and benefits!
Forget about DTC...someone get CAP, ACLA, AMP, ACMG on the horn, because this sure looks like the basis for a class action lawsuit.