Dear Pathway Genomics,
We haven't met, but I feel I already owe you my thanks.
It's difficult to provide real-world examples of companies who badly screw up their regulatory strategy because most of them do so in private, under the cover of heavy non-disclosure agreements. Thanks to your willingness to invite FDA enforcement in public, we now have a handy example to refer back to.
Your public statements yesterday make it clear you don't yet understand what a world of hurt you're in for, so allow me to explain in greater detail than I could afford in my first reaction.
The FDA is not like those other federal agencies you may have heard of. It's a lot less Keystone Cops and a lot more CSI. These are really smart people who are very well resourced. You may think you've found a magic loophole in the regulations, but I assure you that whatever you think you've found has been hashed over 100 times in private meetings with FDA and already denied. You're playing on their home court and they already have extensively-prepared arguments denying the request that you haven't even bothered to make yet.
So when you say that you aren't diagnosing disease, please know that you're wrong. It doesn't matter what you think "diagnosis" means, it only matters what they think it means. And what you're promising to do falls comfortably within their definition of "diagnosis." Describing your offering as having some sort of "entertainment use" does not change the diagnostic nature of the information you're providing.
The thing is, it's not even about what happens in your lab. It's about the specimen tubes. Those are unambiguously medical devices. You probably disagree, so let me cite some sources.
Your collection tube is likely a Class II medical device similar to the Paxgene Blood RNA System. To make this easy, start with these regulations in 21 CFR: 866.2900, 862.1675. Don't take the reference to "blood" too literally in that last one, as FDA has already applied it to saliva collection previously: K970357. Also see 866.4070. This is for RNA, but I'm sure they'd be happy to write a new reg for DNA if you insisted.
Nothing else you do or say is going to change those basic facts. You are openly and flagrantly violating federal law and the authorities have already announced they are investigating you. Just to be clear, when the FDA says they are "investigating" they don't mean it in a non-threatening way. They mean it the way the police mean it when they say they are investigating you.
As you well know, personal genomics is a very edgy industry anyway. It's not the least bit clear what the quality of this information is yet. Telling people that they are at risk for something is a very big deal and you had better be prepared to do some hard-core studies to back up that claim. Not only are current SNP studies limited in scope and depth, the very basis for using SNPs for disease identification is, as yet, unproven.
FDA has been content to let the cottage genomics industry figure itself out a little bit, so long as they behaved and continued to operate as CLIA labs. You've just crossed the exact line they didn't want anyone to step over. I wouldn't be surprised if you've put a number of other personal genomics businesses at risk, too.
In any event, thank you. It's not often that that diagnostic regulatory issues make it to the evening news. I do appreciate your creating a teachable moment for the rest of us.
All my best,
UPDATE: FDA has reportedly released a letter they sent Pathway, giving them 15 days to demonstrate that it has regulatory approval. That's the first step.
UPDATE 2: Walgreens has announced they're pulling out.