FDA Stops Consumer Available Genomics Testing
A few weeks ago, Pathway Genomics, a consumer genomics company, had planned to have its saliva kits at all US Walgreen’s drug stores. The FDA put a stop to it. Congress is now investigating the matter. What is going on here?
This segment is about the whole flap regarding consumer genomics. A few weeks ago, Pathway Genomics was going to start a United States-wide drugstore availability of their genomics kit in Walgreen’s — 7,500 drugstores around the country. In fact, it was planned in August to do the same with the CVS drugstores.
It was really interesting to watch because then the FDA sent a letter to not just Pathway, but also the other companies that do consumer genomics and genome-wide scans such as Navigenics and 23andMe, and said, “We don’t find any approval for this test.” And shortly after that, there was a Congressional investigation led by Congressman Waxman.
Why would this happen? We know that these tests, these genome-wide scans and high-throughput genotyping, are widely available through the internet and have been for more than a couple of years. Just because of the encroachment, if you will, into drugstores to have a saliva kit to be available, is this enough reason to start clamping down on these consumer genomics companies, which do very accurate high-throughput genotyping for what many would consider a reasonable price?
What appears to be the case is this kind of Big Brother paternalistic approach that individuals don’t really have the right to have genome-wide scanning because the data are not adequate to make any medical guidance. Well, this is really kind of interesting because we know there are a lot of particularly pharmacogenomic results that actually could have a big difference, things like the response to Plavix, the inflammation that one can get after exposure to statins, even such things as just caffeine and risk of heart attack. And these were, in fact, available through Pathway Genomics for a $79 charge of all the known, established pharmacogenetic tests. Similarly, Navigenics and 23andMe are providing these.
So this is something that is really interesting — to have, essentially, regulatory governmental oversight bearing down on this group of companies. I think it is really a problem. I don’t see the difference between having these different kits available through the web as compared to having a drugstore presence.
But this is interesting and I would certainly like to get your comments. It seems to me that, in order for this whole democratization of genomics to be in the hands of consumers, this is a necessary step that is inevitable. One could argue that it is a little early, too early in the process and a lot of the data can’t really provide great individualization of risk or therapies. That may be the case, but it is a good way for consumers to learn, and certainly the prices for these types of tests have come down considerably over the years.
Soon, we will be releasing the results of our 5,000 individual cohort who had consumer genomic-wide scanning and had followup to see the impact and that will be interesting, as well.


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