Pathway announced Tuesday that it was going to start selling a saliva collection kit in Walgreen's this week (everywhere except New York) so we could all start gathering our DNA and sending it to Pathway to get tested.
Last night, less than 48 hours later, Pathway abruptly backed down after the FDA intervened and Walgreen's squashed the idea, at least for now.
Pathway's saliva collection kit is a little like razor blades, which aren't much use without the razor. The kit was supposed to sell for $20 or $30, but you'd have to spend much more than that to get your test results -- $79 to see if you react badly to certain drugs, $179 to see if you carry certain genetic diseases ("pre-pregnancy planning"), and $179 to see if you're susceptible to over 70 diseases, from cancer to diabetes to psoriasis. Buy all three tests, and you save $188.
In a letter dated Monday -- the same day that a story about Pathway's plans was leaked to the New York Times -- the FDA said it couldn't find Pathway's FDA clearance for selling a medical device.Did Pathway think it didn't need a clearance? If so, please tell the FDA why.
A spokeswoman for the FDA told me this morning that Pathway has crossed a line by trying to sell its product in a national drug store. "They refer to their end user as a customer, but the agency says they're patients," says Cecily Jones. "That right there is a clear distinction between the FDA and its interest in public health versus these manufacturers who are looking at it more from a business perspective.
"The information they're giving is medical information -- that's the concern. What information or what kind of diagnoses or prognoses or decisions or mistreatments or adjustments may be made on the basis of the results of those tests?"
Jones said the FDA is still deciding how to treat Pathway and companies like it -- two competitors are Navigenics and 23andMe -- as a group. (Navigenics, by the way, issued a blog post today on the Pathway situation called "Working closely with regulators -- a Navigenics core principle." It claims to be the only personal genomics company licensed by the state of New York, which has the toughest laws.)
Is all this a tempest in a teapot? I don't think so. Millions of dollars of venture capital has gone to personal genomics testing companies, and there are other companies, especially in Silicon Valley, that are racing to improve gene sequencing so we can get more and more information from our DNA. Those companies, which include Pacific Biosciences, require some very big and interesting IT to get the job done and will be the subject of another post.
In the meantime, I think it's good that the FDA is asking questions about genomics testing and whether the tests work as advertised.
You're not going to get answers from Pathway right now -- they're in hiding. "Let's plan to keep the dialogue going," said a company spokesman as he sent me Pathway's prepared statement ("We respect and understand Walgreen's decision and we are communicating with the FDA..."), and refused to answer any questions.
Below is a video from CBS News on Pathway's tests, which aired Tuesday while the company was still talking to the public.