Pathway Genetics, a company which does direct-to-consumer genetic testing, announced that its test kits will be marketed through Walgreen’s drug stores. Consumers will buy the kits, do a saliva swab, mail it to Pathway’s lab and then can purchase an analysis of the results. Several companies are in this direct-to-consumer genetic testing business, with apparently mixed success. One, 23andme, reportedly retrenched due to lower revenue than expected. (WSJ Article) (Pathway Press Release)
The FDA, however, thinks that the Pathway tests may need to go through the agency’s regulatory process and made a public statement that the company had not done so. (FDA Article) Walgreens responded by saying it didn’t think clearance was needed, saying the tests are similar to other home diagnostic tests it sells like pregnancy tests and drug tests. Pathway said FDA approval wasn’t needed because the tests are not used for the diagnosis or treatment of a disease. Both companies seem to be on thin ice. Pathway’s own press release states that the “information is critical for making well-informed health and wellness decisions.” The sole purpose of these tests is to identify potential health risks, which sounds very diagnosy. And genetic tests for disease propensity are very different from a test which just tells you if you are pregnant or not or if someone is using drugs. As of now, Walgreens has delayed sales pending resolution of the FDA issues. The test kits also will not be sold in New York State, because it has clearly identified these as medical tests which are regulated. A
Pathway obviously was looking for a large distribution channel. Walgreens presumably sees this as another leg of its growing set of health services, buttressed by the core pharmacy business and the in-store clinics. But genetic tests have raised many concerns, particularly when sold directly to consumers. Expecting consumers to know how to interpret and use the results of these tests is unrealistic and they should only be offered in the context of expert medical advice. Stronger FDA regulation is inevitable.