Back in June, the US Food and Drug Administration fired a warning shot across the bow of the nascent direct-to-consumer (DTC) genetic testing industry. The FDA felt that some of the services were marketing their products as medical tests, and therefore had to provide evidence of their efficacy. Since then, both Congress and the Government Accountability Office have looked into the DTC market, raising the prospects for direct government intervention in the market.
On the most basic level, government intervention in this market has the scent of an invasion of privacy. Shouldn’t any citizen have the right to know about the contents of his or her own genome? But it’s difficult to separate that basic level of knowledge from the medical implications it has, which is where safety, accuracy, and privacy issues—and government enforcement of them—come in.
Read the issues and the risks at the source (arstechnica.com)