by Beyond Lab
New York State sent letters to companies offering consumer genomics tests (personal genomome) because the state considers these tests as "medical" test and should obtain a permit before being prescribed by physicians. The 23 companies include Navigenics, 23andMe, Affymetrix, Illumina, and HairDx etc. Some companies claim consumer genomics is educational, therefore should not require special permit. What on earth is this?
--This is a gray area. But considering the massive information (potentially informative at many aspects), I tend to think that consumer genomics belongs to those genetics tests which are not simply educational. Proper regulations are necessary. FDA probably should hold some kind of panel discussion before it really becomes a problem. Cold Spring Harbor Laboratory is holding such a symposium late this year on this topic (both technology and applications). It is a quickly expanding area involving a lot of deciplines, which makes this kind of discussion important.
I am exciting to see what other people say. So please leave your opinions here.