tag:blogger.com,1999:blog-6173393362223742012.post803117729815345930..comments2023-08-24T08:30:25.608-07:00Comments on Gene Sherpas: Personalized Medicine and You: Why DTC Genomics IS Medicine.Steve Murphy MDhttp://www.blogger.com/profile/11774190000307343476noreply@blogger.comBlogger4125tag:blogger.com,1999:blog-6173393362223742012.post-34822004647140002452009-09-04T12:00:12.112-07:002009-09-04T12:00:12.112-07:00THE ONLY DANGEROUS PERSON HERE ARE YOU. LET OTHERS...THE ONLY DANGEROUS PERSON HERE ARE YOU. <br><br>LET OTHERS TO START-UP COMPANIES FOR THE WELL-BEING OF SOCIETY. NOT DISTURB THEIR WORK. EVENTUALLY, EVERYTHING IS GOING TO BE WELL, AND THESE COMPANIES WILL SELL THEIR DATA TO OTHER COMPANIES, FOR RESEARCH AND PERSONALIZATION PURPOSES. <br><br>PEOPLE IS INTELLIGENT ENOUGH TO DECIDE WHETHER TO USE OR NOT THE SERVICES OF THESE NEW COMPANIES. IF YOU ARE JALEOUS, JUST START-UP A SUCCESFULL COMPANY, GET DATA FROM THOUSANDS OF PERSONS, AND SELL THE DATA (OR THE COMPANY) TO OTHER COMPANIES. THAT'S ALL, PLAIN AND SIMPLE, AND YOU GET A LOT OF MONEY.Anonymousnoreply@blogger.comtag:blogger.com,1999:blog-6173393362223742012.post-83308919435642816332009-09-04T12:54:22.954-07:002009-09-04T12:54:22.954-07:00@Anonymous,Huh? How am I dangerous?Have you heard ...@Anonymous,<br><br>Huh? How am I dangerous?<br>Have you heard of Celera's folly?Steve Murphy MDhttp://www.blogger.com/profile/11774190000307343476noreply@blogger.comtag:blogger.com,1999:blog-6173393362223742012.post-3727717204738398252009-09-09T12:39:42.455-07:002009-09-09T12:39:42.455-07:00Just because you use a CLIA facility does not mean...Just because you use a CLIA facility does not mean that you are testing clinically. <br><br>First, CLIA ia a Good Housekeeping seal of approval. Running under CLIA is an assurance to the customer that certain standards are met. That could be a differentiating factor in marketing DTC services, though I'm not sure how many consumers have heard of CLIA.<br><br>Second, a company might want to (or is planning for the contingency of being forced to by regulations) switch to being a clinical entity at some future date. CLIA & GMP are royal pains, but even more so if you have to backfill. Furthermore, they are to some degree a culture -- and you will make sure you have the right personnel and attitude if you start out that way. <br><br>Note: I've never worked in a CLIA facility, but I have worked under GLP/GMP conditions, which I believe have a very similar flavor.Keith Robisonhttp://www.blogger.com/profile/04765318239070312590noreply@blogger.comtag:blogger.com,1999:blog-6173393362223742012.post-32233883979673098402009-09-09T16:40:11.769-07:002009-09-09T16:40:11.769-07:00@Keith,Most of these companies did not start out w...@Keith,<br>Most of these companies did not start out with CLIA labs, it was only through pushing by guys like me did they make the move......<br><br>Good Housekeeping Seal of approval? Wha???? That doesn't make sense to me. In fact, by using a lab that is subject to the CLINICAL LABORATORIES IMPROVEMENT AMENDMENT I am MORE LIKELY to think this test is a clinical test.<br><br>Backfill? These DTC companies backpeddled into this CLIA thing at our insistence.<br><br>They never intended to be clinical, but now I am certain the writing is on the wall here.....<br><br>-SteveSteve Murphy MDhttp://www.blogger.com/profile/11774190000307343476noreply@blogger.com