As far as I'm able to see it, the Pathway Genomics business plan comes from the Underpants Gnomes, to wit:
- Make large, FDA-flaunting announcement
Pathway, you'll recall, was responsible for the Walgreens debacle that helped put DTCG vendors under the hot glare of the regulators. Now they're back for a repeat performance, claiming that FDA has classified their saliva collection tube as Class I, 510(k) exempt.
It will be interesting to see what gets published first: the retraction or the warning letter. I expect to see one or the other pretty soon.
UPDATE (9/29/11) FDA weighs in: "Registration is not a classification process"