23andMe, the genetics company, is expanding its Personal Genome Service to the UK market. Perhaps wary of the troubles that have plagued the company in the US, 23andMe notes in its UK press release that its services are not diagnostic. That doesn't stop the company from promising to reveal risk factors and genes for sickle cell anemia, cystic fibrosis, Alzheimer's disease, and Parkinson's disease — using the same health reports that US officials have suspended.
The Personal Genome Service's health reports were suspended by the US Food and Drug Administration in November 2013, when the FDA ruled that the company was in violation of federal guidelines. These guidelines require that companies prove the devices they're selling do what their marketing materials say they do, usually via a number of scientific studies that can take years and cost millions or billions of dollars. 23andMe was billing itself as a "first step in prevention," to help users in "mitigating serious diseases." Those count, to the FDA, as medical claims, and 23andMe hadn't done the research required to back them up.
A month later, The New York Times reporter Kira Peikoff wrote about her experience with genetic analyses from three companies, including 23andMe. Her results varied widely between the companies, emphasizing that the personal genome revolution wasn't ready for prime time.
In June, the company announced it had submitted a health report to the FDA for approvalThings have gotten a bit cheerier for 23andMe since then. In June, the company announced it had submitted a health report to the FDA for approval. The report would provide customers with their risk of Bloom syndrome, a rare inherited disorder which increases cancer risks and makes people with the syndrome very sensitive to sunlight. In a blog post explaining the move, 23andMe said it expected this test to help establish parameters for submitting more data to the FDA for future reports.
But even the stripped-down version of the test — right now, US consumers can see ancestry information and raw data, but no health reports — can cause trouble. In September, a reproductive biologist found out from a 23andMe test that he had a half brother, leading to his parents' divorce. That scuttled a plan for 23andMe to turn its "DNA relatives" test from opt-in to opt-out, Fast Company reported.
Even the stripped-down version of the test can cause troubleIn October, 23andMe expanded to Canada, and is now bringing its health reports to the UK. Customers in both countries will be able to receive more than 100 health-related reports in both countries — the reports that the FDA won't allow, because the FDA says 23andMe hasn't proven their accuracy. There's no indication Health Canada will bar the tests from the Canadian marketplace on similar concerns, according to The Globe and Mail.
When I called 23andMe to ask about the UK expansion, Catherine Afarian, the director of public relations, declined to discuss it. She said the company couldn't work with me, as a US-based reporter, because the FDA wouldn't allow 23andMe's health reports to be marketed or promoted in the US.
She sent the following statement by e-mail: "23andMe’s health reports are not cleared by the FDA and can only be purchased in the UK by UK residents. US customers may purchase 23andMe’s ancestry-only product, which provides access to their uninterpreted raw genetic data."