Consumer genetics needs more transparency, not excessive regulation

Recent announcements by the US Food and Drug Administration and Congress suggest an impending regulatory crackdown on companies offering genetic information directly to consumers. In an article on Xconomy, Dan Vorhaus and I argue that the best way forward is not to bring in strong regulation, but rather to encourage the industry to move towards greater transparency.

An excerpt from an article I co-wrote for Xconomy with Genomics Law Report's Dan Vorhaus - link to the full article below.


*Are you ready for consumer genetics? Is your government?

Recent announcements of federal investigations into the budding direct-to-consumer (DTC) genetic testing industry suggest that authorities are preparing to increase regulation of companies offering consumers access to their own genetic data. However, rather than rushing in to clamp down on the industry, regulators should slow down and focus, first, on understanding this complex field.

An increasing number of individuals are exploring their genetic information using tests purchased directly over the Internet. For between $100 and $1,000 consumers can purchase a saliva collection tube, spit in the tube, and mail it back to the company. A few weeks later the results are available online. One DTC genetics company, 23andMe, recently announced that it had provided its test to over 30,000 customers.

Genetic tests can provide the consumer with personalized information ranging from eye color, to ancestry, to risk of common diseases such as diabetes. Many companies include all of these traits and more in a single product examining hundreds of thousands of genetic markers. For the moment, these tests are available to anybody with a computer and a sense of curiosity. But that could all change.

Read the full article at Xconomy.

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