Late in 2014, 23andMe launched its direct-to-consumer personal genetics service in Canada and the UK. For the Mountain View, California–based company, the move into smaller markets marks a new horizon for the company since suspending its US health-related genetic testing almost a year ago following a warning letter from regulators (Nat. Biotechnol. 32, 1, 2014). Also, last month, 23andMe partnered with Genentech of S. San Francisco, California, to provide whole genome sequence data to fuel discovery of Parkinson's disease drugs, a further sign that the personal genetics company remains committed to exploring new routes to revenue.

23andMe's co-founder and CEO Anne Wojcicki Credit: STEPHEN LAM/REUTERS/Newscom

British medical geneticists were skeptical about the likely uptake of the £125 ($189) spit test in the UK. “I don't have a sense that there is a great appetite for direct-to-consumer patient testing in the UK,” says Bill Newman, professor of translational genomic medicine at The University of Manchester, and chair-elect for the British Society for Genetic Medicine. He pointed to previous products from genomics testing companies that have failed to succeed in the UK, including one test that was briefly sold by cosmetics store The Body Shop, acquired in 2006 by L'Oreal.

Anneke Lucassen, professor of clinical genetics at the University of Southampton and member of the Nuffield Council on Bioethics, agrees. “There is a slightly different mentality here than there is in the States,” she notes, adding that people tend to be less willing to pay for private healthcare tests because the National Health Service covers the costs of necessary medical tests.

Canada, too, has a universal healthcare system and just over half the population base of the UK.

23andMe has not disclosed its market expectations for the UK and Canada. But before the company launched in the UK, 10,000 British consumers had signed up for 23andMe's services, paying an additional shipping fee from the US. 23andMe has a total of 800,000 customers.

23andMe is continuing to work with the FDA to get its tests approved in the US, says a company spokesperson, adding that a 510(K) application for a Bloom Syndrome report currently under review by the agency “could provide a foundation for future submissions.” Newman and Lucassen speculated that one motive for the new launches could be to smooth discussions with the FDA. “My feeling is that coming into Europe is just the company's way of trying to get in through the back door. They might then be able to say, look, we launched it successfully in Europe, and use that as a means to appeal to the FDA to relaunch it in the states,” says Lucassen.

In the UK, the company will sell DNA kits and reports on 43 inherited conditions (including cystic fibrosis and sickle cell anemia), 12 drug responses (including Plavix (clopidogrel) and Coumadin (warfarin)), 11 genetic risk factors (including Alzheimer's and Parkinson's) and 40 traits (including alcohol flush reaction and ear wax type). The test will also provide genetic ancestry data and enable UK customers to participate in 23andMe's genetic research program. In Canada, the spit test covers two additional inherited conditions and two additional traits. “Information from certain reports could be incorporated into the management of an individual's healthcare upon consultation with a doctor,” says a company spokesperson. “Other results are simply interesting and informative.”

For Newman, however, the clinical utility of many of 23andMe's genetic analyses remains debatable. With the additional caveat that, if genetic information isn't conveyed or interpreted properly, customers may be falsely reassured or unnecessarily stressed by the results. “I can't quite see the benefit of this type of testing for myself or for many people,” he says, “but that's not to say that people shouldn't have the choice to have that testing.”

The deal struck with Genentech is not based on selling DNA tests but on data collected from its consumer base. According to Forbes, Genentech paid $10 million upfront and committed $50 million in milestones. Under the terms of the collaboration, 23andMe will carry out whole genome sequencing in approximately 3,000 people with Parkinson's disease to generate therapeutic target leads. In the past, 23andMe has struck similar deals with other drug developers, including a deal last year with Pfizer of New York to study the genetic factors associated with inflammatory bowel disease. (Nat. Biotechnol. 32, 967, 2014)