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News Briefs: 23andMe’s Mea Culpa; FDA Reaches Settlement With J&J; Meaningful Use Delay

Genetic testing firm 23andMe has stopped providing its genetic tests to consumers, following a warning letter from FDA. The agency has reached a $1.25 million settlement with Johnson & Johnson’s Advanced Sterilization Products group. HHS agencies announced delay in health IT meaningful use implementation. More news.

The direct-to-consumer genetic testing firm 23andMe Inc. has stopped providing consumer access to its health-related genetic tests, including the Personal Genome Service, pending completion of an ongoing regulatory review and approval by FDA, the firm said in a statement Dec. 5. The company will continue to provide consumers both ancestry-related information and raw genetic data without interpretation, although those customers who purchased their Personal Genome Servicetest kits prior to Nov. 22, when FDA issued a “cease and desist marketing” warning letter, will still receive health-related results. (See Also see "FDA Comes Down Hard On 23andMe, Putting Consumer-Directed Genetic Testing On Notice" - Medtech Insight, 25 November, 2013..) Customers who purchased kits on or after Nov. 22, 2013 will be eligible for a refund, the firm says.

“Our goal is to work cooperatively with the FDA to provide that opportunity [for people to access their own genetic data] in a way that clearly demonstrates the benefit to...

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