By Andrew Pollack
June 16 (Bloomberg) -- Navigenics Inc. and 23andMe Inc., are among 13 companies ordered by California regulators to stop selling genetic tests to consumers in the state until they show they can meet government rules for clinical laboratories.
Businesses that offer DNA screening must hold state and federal approvals as laboratories and provide tests in response to requests from licensed physicians, said Lea Brooks, a spokeswoman for the California Department of Public Health, in a telephone interview today. Brooks said the state wouldn't name the companies, which offer their services primarily through the Internet, until officials knew all of them had seen the orders.
Navigenics and Google Inc.-backed 23andMe, which said they received the state's letter, are among the most high-profile in a fledgling industry trying to make genetic tests available to consumers. People are seeking gene scans for signs they might have a risk of diseases such as cancer, Alzheimer's or diabetes.
``We have received multiple consumer complaints about the accuracy and costs of genetic testing advertised on the Internet,'' Brooks said.
Navigenics complies with all the requirements of California's law and has contacted state health regulators to answer their questions, the closely held company based in Redwood Shores, California, said in a statement. ``Additionally, Navigenics encourages its customers to utilize its team of genetic counselors to help understand the personalized information provided,'' according to the statement.
`New Service'
Rachel Cohen of Mountain View, California-based 23andMe said the company recognizes regulators have questions about how this ``entirely new informational service'' fits under current laws. 23andMe is ``eager to work with them in the development of an appropriate regulatory framework for the personal genomic industry,'' Cohen said in an e-mail today.
The 13 companies have two weeks to show California authorities they meet the rules or provide a plan to do so, Brooks said. The state can fine or refer businesses to local district attorneys for criminal prosecution for failing to comply with the regulations.
To contact the reporter on this story: Andrew Pollack in San Francisco at apollack1@bloomberg.net
Last Updated: June 16, 2008 22:09 EDT
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