SAN FRANCISCO (Reuters) - Silicon Valley-based genetic testing company 23andMe is looking for new growth of its direct-to-consumer DNA tests abroad, building on recent expansions into Canada and the UK.
The company, whose consumer-directed tests were barred by U.S. health regulators in 2013, said Western Europe is one focus for expansion. It is also exploring regions where it sees the most need, 23andMe Co-founder and Chief Executive Anne Wojcicki said in an interview.
The U.S. Food and Drug Administration has said it fears the genetic information and analysis provided by 23andMe could be misinterpreted by customers. More than 800,000 people have taken the test globally. Neither Canada or the UK required premarket approval for distributing its tests, the company said.
23andMe’s international expansion is part of a plan to reach an “unprecedented” number of consumers. Since the FDA decision, the company has continued to sell genealogy information to U.S. consumers and has also reached several sequencing deals with research institutions and drugmakers, which will use the data in a controlled environment.
“I want billions (of consumers),” Wojcicki said. “We would never have started this company if we didn’t have unrealistic goals.”
The company and the FDA are discussing its application, made last year, to test U.S. consumers for genetic predisposition to a rare disease known as Bloom Syndrome, which is characterized by short stature and can result in cancer.
Wojcicki, speaking on the sidelines of the J.P. Morgan healthcare conference in San Francisco, said 23andMe is looking for new markets that have the proper legal framework, as well as the need for more genetic testing. Southeast Asia is one region with an urgent need for more genetic data, she added.
Wojcicki said Europe is also an immediate focus since the company has already received a CE mark, a product certification for the region. In China, however, local laws would not allow 23andMe to move genetic information outside the country.
23andMe is also studying countries that prohibit discrimination on genetic grounds or that have plans to introduce such laws, Wojcicki said. In Canada, for instance, 23andMe is supporting new legislation along these lines.
(This story corrects regulatory approval to CE mark certification in eighth paragraph, clarifies that the FDA application has been made in seventh paragraph)
Reporting by Caroline Humer and Christina Farr; Editing by Michele Gershberg and Andre Grenon