tag:blogger.com,1999:blog-6173393362223742012.post3980049135849913168..comments2023-08-24T08:30:25.608-07:00Comments on Gene Sherpas: Personalized Medicine and You: Answer to GenomicsLawyer's Question. What the FDA will do with DTCG.Steve Murphy MDhttp://www.blogger.com/profile/11774190000307343476noreply@blogger.comBlogger3125tag:blogger.com,1999:blog-6173393362223742012.post-81236441951150741452010-06-17T08:10:15.771-07:002010-06-17T08:10:15.771-07:00@Stuart,
I tend to agree. But this is the current ...@Stuart,<br />I tend to agree. But this is the current example. There are several far more versed in the AmpliChip story including Mike Phillips who thinks this was an abomination of an approval. It may be so, but it is what is currently out there. Will the FDA be more stringent with the LDT move? Probably, but this serves as a good counter point.Steve Murphy MDhttps://www.blogger.com/profile/11774190000307343476noreply@blogger.comtag:blogger.com,1999:blog-6173393362223742012.post-24183503766273089032010-06-17T03:06:05.299-07:002010-06-17T03:06:05.299-07:00Amplichip is a bad example of what will happen, as...Amplichip is a bad example of what will happen, as Roche made only very general claims about the clinical validity of P450 testing. The types of claims which Navigenics et al make about gene-disease relationships are far more specific.Stuart Hogarthnoreply@blogger.comtag:blogger.com,1999:blog-6173393362223742012.post-87551561553929373122010-06-12T07:29:07.180-07:002010-06-12T07:29:07.180-07:00What is new is that this new FDA regulation seems ...What is new is that this new FDA regulation seems to be specifically targeting to "software" as "medicine." <br /><br />"Software is a medical device, and they’re making medical claims. They’re taking results and making medical claims that come out of those results." Alberto Gutierrez, US FDA<br /><br />http://www.newsweek.com/blogs/the-human-condition/2010/06/11/why-the-fda-is-cracking-down-on-do-it-yourself-genetic-tests-an-exclusive-q-a.htmlAndrew Yatesnoreply@blogger.com