California genome testing companies reject Health Department orders to cease operations

Consumer genome testing companies Navigenics Inc. and 23andMe, co-owned by the wife of Google co-founder Sergey Brin, refused orders of the California Health Department to cease accepting clients by continuing operations on Wednesday, a day after the orders were posted on the web. They aver that that their operations already follow the law.

The two Bay Area companies are among 13 genetic testing outfits that were ordered to cease and desist this month by the state Department of Public Health. Other prominent names include Knome Inc. in Cambridge and deCODEme Genetics of Iceland.

The government agency warned the companies that they must obtain a clinical laboratory license before conducting medical tests for Californians. In addition, the agency said the companies couldn't offer laboratory tests directly to California consumers without a doctor's order.

"The intent of California's clinical laboratory laws is to protect the public by ensuring that results are accurate and reliable," the state Public Health Department said in a statement issued Tuesday. "The physician assists the patient by ensuring that appropriate tests are ordered and interpreting the test results."

New York also sent letters to a half-dozen genetic testing firms a few months ago. But federal agencies are still discussing whether to take any action, said Gail Javitt, law and policy director of the Genetics and Public Policy Center at Johns Hopkins University.

Navigenics of Redwood City offers clients a $2,500 scan of their DNA for signs that they might be at higher risk for diseases such as cancer, diabetes and other ailments that may be preventable by improving health habits.