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California Grants Navigenics, 23andMe Licenses to Offer Services in State

This article has been updated to include comments from Navigenics.
 
NEW YORK (GenomeWeb News) – California will allow two of the fourteen consumer genomics companies it slapped with cease and desist letters two months ago to again market their genotyping services in the state, the state’s Department of Public Health confirmed Thursday.
 
The CDPH inspected both companies, and on Aug. 7 it granted a license to operate in the state to Navigenics and a week later it gave one to 23andMe. Both of these companies were among the group that CDPH in June said were operating outside of state regulations.
 
“State law requires these laboratories to have a license, obtain a physician's order from the consumer and demonstrate how they validate the results of their tests,” CDPH spokesperson Lea Brooks told GenomeWeb Daily News in an e-mail.
 
Brooks also said that “several” other of the companies that received the cease-and-desist notification have now applied for licenses in the state, but noted that the state is not currently disclosing further information about how it is investigating the other laboratories.
 
Navigenics and 23andMe both are headquartered in California.
 
Rachel Cohen, a spokesperson for 23andMe, told GWDN that the company has been involved in discussions with the state for “a few weeks” and that the firm is “happy” that the state was satisfied with the company’s processes.
 
The firm is not commenting on the discussions it continues to have with the state, Cohen said, but she confirmed that 23andMe has satisfied the state’s regulation for physician oversight without providing details.
 
California may have had a breakthrough over how to gauge the validity of consumer genomics when it opted to review Navigenics’ analytical service as a lab, company CEO Mari Baker told GWDN today.

She said that the state quelled its concerns over the validity of the service when it focused on how the company performs its analysis, “and they were satisfied with what they saw, with our appropriate quality controls.”

The company’s genotyping function, the chemical end of the service, is provided by Affymetrix, which has a licensed lab in California.

“This is all a new area, and the state was incredibly responsive in dealing with us and others,” Baker added, saying the state “tried to really dive in and understand how we do what we do and if it’s reliable and replicable for consumers.

Baker explained that CDPH reviewed the company’s “processes and procedures to ensure that consumers have some degree of quality and confidence in what they’re getting.”

Navigenics also has been involved in discussions with the Centers for Medicare and Medicaid Services, which Baker suggested may offer a solution in the future for the consumer genomics field by adopting a federal framework.

In addition, the firm is opening communication lines with the states “one at a time,” she said. The company also recently has been licensed by the state of Maryland, and has been working with the Personalized Medicine Coalition to develop an approach for federal and state regulators, she added.

“I hope this [California approach] could be a benefit to help give people confidence in the quality and allow us to keep moving forward, to educate physicians, and to educate consumers,” Baker said.

 

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