Tuesday, July 22, 2014

The FDA won't let 23andMe test your genes — so it may go to Europe

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The personal genetics startup 23andMe may start selling its products abroad after facing barriers with US regulators.

According to Reuters, a company spokesperson confirmed that 23andMe was "evaluating international opportunities." An unidentified anonymous source told Reuters that the company is planning to enter foreign markets by the end of the year.

23andMe is arguably the most popular in a growing field of businesses offering inexpensive gene testing directly to consumers. Regulatory agencies around the world are rushing to catch up and figure out where they stand.

Trying to fit this new technology into an old regulatory framework produces some weird comparisons. Should something that provides an analysis of genetic risk be classified as a medical device like a pacemaker or a hospital's gene testing kit? Or is it more similar to a fitness tracker like a Fitbit — which anyone can buy off the shelf? Or somewhere in between?

What happens with 23andMe will force agencies to set up rules and precedents that will likely affect the regulation of bioinformatics for decades to come.

The US is generally more cautious than Europe when it comes to medical devices. It's common for new devices to be approved in Europe years ahead of when they are in the United States. The Reuters story also suggests Canada and Australia as potential markets.

23andMe, which is based in Mountain View, California, had been selling a $99 package that included analyses of people's ancestry and of genetic risks of 254 diseases and conditions, including breast cancer, heart disease, and Type 2 diabetes. It had about 500,000 customers.

Then last year, the FDA ordered the company to stop selling the kit, which the regulatory agency considers to be an unapproved medical device. The letter states that 23andMe had not provided enough evidence of accuracy and that people could be harmed by, for example, getting false results from its breast cancer risk assessment. Although the company stated that it stands by its testing standards, it has complied and dropped health analysis from its offerings. It currently sells a $99 kit with ancestry analysis and raw data.

Further reading:

Correction: Clarified that Europe is generally faster than the US on devices, not necessarily on drugs.

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