|23andMe CEO Anne Wojcicki|
23andMe has found regulators in the United Kingdom more amenable to its personal genomics service than the U.S. FDA. The U.K. Medicines and Healthcare Products Regulatory Agency (MHRA) has given cautious backing to the Google ($GOOG)-funded company's spit test, which has a CE mark clearing it for sale in Europe.
Consumers in the U.K. can now buy the test for £125 ($196)--significantly more than it costs in the U.S.--and will receive a report detailing 100 genetic health factors. The report is what landed 23andMe in hot water with the FDA, which issued a warning letter for making medical diagnoses without the necessary approvals or evidence. In a press release about the U.K. expansion, 23andMe said its tests aren't diagnostics. It has also removed many of the risk factors that riled the FDA from U.K. reports.
Before the warning letter, 23andMe's reports covered the risk of 254 diseases and conditions. The U.K. report includes more than 100. A spokesperson for the Department of Health (DOH) told BBC News: "Many of the drug responses, inherited conditions and genetic health risks that were of concern in the U.S. have been removed." The DOH and MHRA have both warned consumers to think carefully before using a personal genomics service, though.
For 23andMe, the expansion into the U.K.--which follows its move into Canada--gives it a fresh source of income at a time when it is still working through its disagreements with FDA. The expansions could also swell the pool of people who contribute genetic information to the databases that underpin the research side of 23andMe's business. In the year since receiving the warning letter, 23andMe has continued to deepen its interest in research through a deal with Pfizer ($PFE) and other initiatives.
However, the coexistence of the research and personal genomics businesses is an issue for some people. "It's not entirely clear what their business plan is--whether they want to make money by selling kits to consumers, or whether they want to make most of their money by selling consumer data to other companies," Professor Hank Greely, director of the Center for Law and the Biosciences at Stanford University, said.