“FDA is concerned about the public health consequences of inaccurate results from the PGS device,” the agency said today. “The main purpose of compliance with FDA’s regulatory requirements is to ensure that the tests work.”
The FDA used candid language in the letter to outline the work the agency has done with 23andMe since 2009 to no avail, including more than 14 face-to-face and teleconference meetings and had hundreds of e-mail exchanges. The FDA said it has given the company feedback on study protocols, discussed regulatory pathways and provided statistical advice.
[Here’s the thing… genetic testing can’t tell you whether or not you will develop a disease, only whether you carry a gene mutation that *statistically* puts you at a higher risk. Meaning they’ve found a correlation, but as far as I can tell, no one knows whether an individual gene by itself affects anything. It seems quite the opposite from what I’ve read… changing one gene seems to cause other genes to change as well and explain why in part all this is such slippery stuff… why there are no “cures” being batted about. (Yes, I know people are working on all kinds of stuff, but it all runs counter my experience that this form of “reductionism” applies well in complex systems.) Negative tests for a given gene mutation also don’t mean that you’re in the clear: For example it seems that only ~5% of breast cancers and maybe as much as 15% of ovarian cancers are caused by hereditary mutations in BRCA1 and BRCA2 the genes made somewhat famous by Ms. Jolie. As always, I’m not telling anyone what to do, and certainly if you’re not relying it diagnostically have at it. But between the margin of errors in the tests themselves, the limited number of markers that a service like the above checks, etc… seems like a really low grade indicator of anything. I know it appears high tech and shiny, but that doesn’t mean it’s accurate or reliable, or that we have any idea what it means when we see it.]