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California Letters to Consumer Genomics Firms Cite Lab Certification, Physician Oversight

NEW YORK (GenomeWeb News) – Lab certification and physician oversight are the two primary issues that the State of California has with consumer genomics firms, which it believes are running afoul of state law.
Last week, the California Department of Public Health sent warning letters to thirteen consumer genetics companies telling them to stop offering their tests to the state’s residents. Two firms that have confirmed that they have received letters from the CDPH include DNATraits and Navigenics.
Houston, Texas-based DNATraits specializes in genetic testing to identify susceptibility to inherited diseases and characteristics. The letter it received from the CDPH, posted yesterday on the website of the magazine Wired, stated that by offering its service to California residents over the internet DNATraits is violating state Business and Professions codes concerning clinical licensing and physician oversight.
Navigenics, which is based in California, said that it believes its service is in compliance with the law. The firm sends its tests to Affymetrix's CLIA lab for processing.
In order to be licensed in California, the letter states, the company “must provide satisfactory validation documentation to verify the test performance specifications of all genetic tests.”
According to California law, which was cited by the CDPH, “No clinical laboratory license shall be issued by the department unless the clinical laboratory and its personnel meet the CLIA requirements for laboratories performing tests or examinations classified as of moderate or high complexity, or both."
The letter also said the companies are violating a code that prohibits the offering of a clinical laboratory test directly to consumers without a doctor’s order, except in special cases.
The state also requires that tests that are not subject to US Food and Drug Administration clearance meet certain performance specifications for accuracy, analytical sensitivity and specificity, and precision, among others.
Until companies offering these genetic tests apply for and obtain licenses for performing such services in California, they must include a clause in their advertising saying that their services are prohibited for California residents.
DNATraits and the CDPH did not return calls or e-mails as of press time.
However, Navigenics e-mailed a statement to GenomeWeb Daily News saying that it would work with the CDPH to resolve the department's concerns.
“We are confident that our approach, which incorporates physicians, genetic counselors and a CLIA-certified lab, is evidence of our commitment to quality and compliance while providing consumers with a valuable health and wellness service,” Mari Baker, president and CEO of Navigenics, said in the statement. 

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