gene

Two closely watched companies that offer consumers information about their genes have received licenses that will allow them to continue to do business in California, a state official said Tuesday.

The licenses, granted to Navigenics and 23andMe, should help defuse a controversy that began in June when the California Department of Public Health sent “cease and desist” letters to the two companies and 11 others that offer genetic testing directly to consumers.

The letters said that companies could not solicit customers from California without receiving a license from the state to operate as a laboratory. And they said that doctors had to be involved in ordering genetic tests.

The letters were the most recent sign of concern that regulators at both the state and federal level are becoming increasingly concerned about the accuracy and validity of tests being sold through the Internet.

But the state’s action also sparked concern that overregulation could stifle a promising new industry. The media coverage of the action seemed to catch the state off-guard. Both sides appeared eager to resolve the issue.

“I think we’re very satisfied that they have met the California requirements for licensure,” Kathleen J। Billingsley, a senior official in the California public health department, said in an interview Tuesday. http://louis-j-sheehan.biz

Navigenics and 23andMe attracted the most focus of the companies receiving the letters. Both are based in California’s Silicon Valley and both offer services, costing from $1,000 to $2,500, that scan a person’s whole genome, providing a variety of information about the risk of various diseases. Google is a backer of 23andMe, and one of the company’s founders, Anne Wojcicki, is married to a Google co-founder, Sergey Brin.

The companies had argued that they were not offering medical testing but rather personal genetic information services, and that consumers had a right to information from their own DNA. The companies also said they did not need a license because the actual testing of the DNA samples was being done by outside laboratories that did have licenses.

But the two companies do their own interpretation of the raw genetic data. Now, after reviewing the procedures used by the companies, the state is satisfied that the companies’ interpretation is based on the scientific literature, Ms. Billingsley said.

Ms. Billingsley said the companies also satisfied the requirement for a doctor to be involved. Navigenics already was paying a physician to review customer orders and now it appears that 23andMe might be doing something similar.

Linda Avey, a founder of 23andMe, declined to say on Tuesday what the company was doing regarding doctors. She said the company wanted to assure customers first that their privacy was being protected.

Mari Baker, chief executive of Navigenics, said she was satisfied with the outcome.

“It’s a situation that in the end everyone wins,” she said. “In the end the state moved really quickly through this process. They were incredibly responsive.”

DeCode Genetics, an Iceland-based company that offers a similar gene-scanning service to consumers, has also applied for a license, and the state has asked it for more information, Ms. Billingsley said.

She said four of the companies that received the letters in June had agreed not to solicit California customers, and the rest were either applying for licenses or talking to the state agency.

Both sides agreed that regulations would continue to be reviewed. “We wanted to try to work within the existing regulations but we think there will be an ongoing discussion of regulations in this new space,” Ms. Avey of 23andMe said.

Ms। Billingsley, who is deputy director of the state’s Center for Health Care Quality, said the department would continue to review its approach “to make sure that the state’s requirements and our standards keep up with changing technology.” http://louis-j-sheehan.biz

New York State also has taken action against at least 31 genetic testing companies, saying they cannot solicit business from New York residents.

Ms. Baker of Navigenics said a resolution with New York did not seem imminent. “We do think in the end this needs to be regulated at the federal level rather than as a patchwork of state regulations,” she said.