Dan Vorhaus JD on his blog says "The path of least resistance may be to simply agree with the FDA....The viability will depend on how the FDA intends to categorize the specific product...."
I agree, these companies have big choices to make. If it is any indication, Counsyl (full of smart people) and now, Pathway Genomics (full of smart people) have both decided to go the route of Medical test.
Perhaps it is because they think the burden will cost less to investors than fighting the "Man"
Well, in guessing what the FDA will do, it is always best to see what they have done to a "similar" product. In this case, they have a great product that is very similar. That would be the FDA's approval of AmpliChip.
A friend of mine in Canada argues about the holes in this platform, but unfortunately it is the only FDA approved platform.
You can read the letter for the FDA approval here
This was cleared in 2005! I wonder if the DTCG companies ever looked at AmpliChip as a model before?
In the letter it is clear, microarray technology used for drug metabolism prediction is considered a Class II medical device. The letter indicated that this applied not only to AmpliChip, but also to similar devices.
It also does not waive premarket submission.
Both of these are very important points in how the DTCG groups evaluate their future business models and potential market.
The Sherpa Says: Why Conjecture? Just look at what the FDA decided for AmpliChip. It will be a similar template.
3 comments:
What is new is that this new FDA regulation seems to be specifically targeting to "software" as "medicine."
"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
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.html
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,
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.
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