California warns local gene-testing company
California regulators warned 13 genetic testing companies, including Knome Inc. in Cambridge, to stop marketing their products in California unless they comply with state licensing and testing laws.
The California Department of Public Health warned the companies that they must obtain a clinical laboratory license before conducting medical tests for Californians. In addition, the agency said the companies cannot offer laboratory tests directly to California consumers without a doctor's order.
"Knome is in violation of California law," the agency warned. "Genetic tests are not exempt" from rules requiring a physician's approval, it said.
Knome is one of more than a dozen companies that have offered to analyze an individual's DNA for markers related to genetic diseases. But critics warn consumers that the industry is largely unregulated and that scientists are only beginning to understand many of the links between DNA and illness.
"We don't know for sure what these products do right now," said Dr. Muin Khoury, director of the National Office of Public Health Genomics. Khoury said DNA sequencing is a "wonderful research tool," but is not ready to be marketed to consumers because it's unclear how much of the data is meaningful for patients.
Knome has gone further than most companies by offering to sequence an entire genome - rather than just key strands of DNA - for $350,000. In January, the company unveiled plans to accept its first 20 patients. It has teamed up with the Beijing Genomics Institute, which will do the actual DNA sequencing while Knome focuses on signing up customers and explaining what the sequence means.
In a statement, Knome chief executive and cofounder Jorge Conde said clients already have a doctor involved in the process, but he did not address licensing.
"While we have not yet officially responded to the letter," Conde said, "we will seek an ongoing dialogue with the California Department of Public Health" about state regulations.
Other companies that received warning letters include 23andMe, deCODEme genetics, and Navigenics. But some companies said they believe they are already in compliance with California law. 23andMe spokeswoman Rachel Cohen said the Mountain View, Calif., company uses a certified laboratory and a California doctor.
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.
"There's been very little action on the federal front," Javitt said, "so it's not surprising that we would see questions being raised by some states."
Todd Wallack can be reached at twallack@globe.com.
