Just days after a lab mix-up at personal genomics company 23andMe, the US Food and Drug Administration is demanding federal regulation for genetic tests marketed directly to consumers. According to the agency, the tests are medical devices, and should be evaluated as such.

The FDA sent letters to five companies on Thursday, saying the tests must go through an approval process before they go on the market. 23andMe and two other companies selling the tests – Navigenics and DeCode Genetics — received the letters, as did the sequencing company Illumina, which sells the gene arrays some companies use in their products, and Knome, which offers consumers whole genome sequencing. Company responses have been variable, the New York Times notes, with 23adnMe saying it disagreed with the FDA’s decision but DeCode saying it welcomed regulation.

You can read the letters from the FDA here.

The FDA isn’t alone in getting antsy about personal genomics. The agency’s demand last month that the Walgreens pharmacy chain halt plans to sell a home genetic test spurred Congress to embark on an investigation of the direct-to-consumer personal genomics industry.

The San Francisco Chronicle had a thoughtful piece yesterday on the industry as a whole, and thoughts surrounding regulations – check it out here.

Cross posted from Nature’s The Great Beyond blog.

Just days after a lab mix-up at personal genomics company 23andMe, the US Food and Drug Administration is demanding federal regulation for genetic tests marketed directly to consumers. According to the agency, the tests are medical devices, and should be evaluated as such.

Read the rest of the post on The Great Beyond.