If I were Pathway, I would take this opportunity to look in the mirror. Whether it was a factor in the FDA’s sudden interest in the company or not, there seems to be a paucity of information on Pathway’s website. There is a list of conditions that Pathway tests for, but there are no details and the list is “current” as of October 20, 2009. In clinical genomics, that’s a long time ago.
More troubling, I think, is the lack of specifics about exactly what’s included in Pathway’s tests. 23andMe, for example, has been completely upfront about what alleles are being screened for in its services. Without giving up my credit card or logging in, I can learn that for cystic fibrosis, the company screens for 31 mutations and that for Caucasians, these variants cover 85-97% of all known mutations; for African Americans, Hispanics and Asians it’s more like 50-75%. Thus, before I’ve spent a red cent, I can know that 1) this test will not get me completely off the hook and 2) my ancestry can have significant bearing on my risk.
My point is, if you want to be taken seriously, not only by the FDA but by docs and, oh yeah, by your customers, then don’t insult us. Give us the technical data, explain what fraction of our risk can be attributed to genes insofar as is known, link out to the primary references, and when the science changes, don’t wait six months to change your website. Indeed, you might want to do it before you launch your national retail marketing campaign.
As I’ve tried to make clear below, I’ve got no problem with genetics in the drugstore. But it’d be nice to know exactly what’s inside the box.