FDA Challenge Raises Questions on Right to Genetic Information

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The genetic-analysis company 23andMe has garnered a devoted following since its launch in 2006. For $99 and a cheek swab, the company analyzes a customer's genetic information for potential disease markers and for genealogical roots, revealing a wide range of genetic information.

Now the Food and Drug Administration (FDA) has ordered the Google-backed company to halt sales of its signature product, the Saliva Collection Kit and Personal Genome Service.

In a letter to the company's founder, Anne Wojcicki, the FDA wrote that 23andMe sold their main product without "marketing clearance or approval." The company released this statement in response.

Nita Farahany, professor of law, genomics and policy at Duke University, took the 23andMe test. She and her now-husband shared their respective profiles on their third date, and she argues that the FDA is overreaching in their regulation of the company.