On Monday, news broke that Walgreens was about to announce a genetic test kit, available in stores starting on Friday. The kits would allow consumers to test for such things as how you respond to statins or blood-thinners; whether you carry genes for Tay-Sachs disease or cystic fibrosis; whether you have an increased risk for coronary artery disease, Alzheimer’s, MS, colon, lung or prostate cancer; and your chances of becoming obese, developing psoriasis, or going blind. There are three separate tests, individually priced, so you don’t have to confront the bad news all at once.
On Tuesday, when the announcement became official, commentators speculated on how the FDA would react. A spokesman for Pathway Genomics, the developer of the test partnering with Walgreens, said: “FDA clearance is not necessary to sell the … Kit in retail.” He also confirmed that the product had not been submitted for FDA approval.
Meanwhile, FDA officials, contacted for their comments, were saying that any test that “could lead to a consumer making a decision on whether they are going to terminate a pregnancy — we consider that a very important decision to be made on a test that has not been looked at by the FDA.”
The FDA requires products that make health claims to be reviewed. Walgreens/Pathway argued that the test provides consumers with “information about their personal genetic makeup and traits,” hoping that would be sufficient to avoid the FDA’s purview.
On Wednesday the FDA made public a letter to Pathway “suggesting” that the kit did need regulatory approval. The FDA was on top of this all along. The letter was actually written on Monday.
Late Wednesday, Walgreens announced it would postpone sales of the kit.
