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Navigenics Hopes NY, Calif. Quickly Resolve Regulatory Issues About Its Testing Service

Though it is less than one year old, the market for personal genetic-testing services is facing a number of regulatory issues. The latest came in the form of a letter from the State of California’s Department of Public Health and was addressed to 13 companies based in the state that offer personal genetic testing services, including Redwood Shores-based Navigenics.
The June 9 letter, provided to BioArray News by a Navigenics spokesperson, alleges that Navigenics is in violation of California Business and Professions Code requiring the company to perform its tests in a clinically licensed facility, and that all of its orders must be performed either by a physician or surgeon.
The state also urges Navigenics to stop serving customers in California until it obtains a license from the CDPH. “In order to be granted a clinical laboratory license, in addition to meeting all other licensure requirements, Navigenics must provide satisfactory validation documentation to verify the test performance specifications of all genetic tests,” the letter states.
Navigenics CEO Mari Baker said she hoped any outstanding issues with California regulators could be resolved “quickly,” and that Navigenics is making itself available to meet with representatives of the state “at their convenience.” According to the CDPH letter, Navigenics was required to respond to the letter by June 23.
Two months earlier, hoping to regulate the personal genetics-testing market in its state, the New York State Department of Health sent 23 warning letters to companies in the market, including Navigenics, 23andMe, Affymetrix, and Illumina, urging them to obtain state permits before offering what it considers medical genetic tests, and to obtain a physician’s recommendation to use personal genetics services (see BAN 4/29/2008).
Baker informed BioArray News that the New York issue has still not been resolved. “Our laboratory, however, has submitted its documentation and we are expecting the lab license to be granted,” Baker said.
United States?
According to Baker, the firm is concerned that other states may follow New York and California’s lead. However, she told BioArray News this week that a quick resolution in both states might clear the way for the personal genetics market to develop without further regulatory requirements.

“Historically, many states look to New York and California for guidance.”

“Historically, many states look to New York and California for guidance,” she said. “I am sure they are following what is happening in those two states. It would be a shame if every state acted separately, [which would] likely result in the same sort of consumer confusion regarding discrimination issues that we saw exist for 13 years until [the Genetic Information Nondiscrimination Act] was just passed,” she said.
While California’s letter ordered Navigenics to “cease and desist” its consumer testing service, Baker said the company continues to perform its tests in the state. She noted that the company already requires the approval of a physician or surgeon for its service, called Health Compass, which uses an Affymetrix SNP genotyping array to screen and counsel patients believed to be genetically predisposed to developing 18 different conditions, including Alzheimer’s disease, multiple sclerosis, prostate cancer, and diabetes.
The company’s samples are processed at Affy’s Clinical Service Laboratory in Sacramento, which passed the California’s survey for Clinical Laboratory Improvement Amendments certification in April 2007 (see BAN 4/24/2007).
“We believe that we are in compliance and are continuing to take orders until we hear otherwise from the state,” Baker said.
That response is different from the company’s approach to the situation in New York, where it has wait-listed customers until Affy’s lab obtains a license from the state to perform medical testing.
Baker drew a parallel between the firm’s relations with state regulators and its relationship with the federal government, which it has engaged through the Personalized Medicine Coalition, a non-profit organization that aims to foster a debate and reach a consensus on various issues related to personalized medicine.
For instance, Navigenics in April proposed 10 standards it believes should be implemented across the personal genetic testing industry. The standards include such criteria as validity, accuracy, clinical relevance, and the need to follow HIPAA regulations and address security and privacy issues, while emphasizing an individual’s right to control who may obtain access to their genetic information (see BAN 4/8/2008).
“Just as we have sought to be helpful and cooperative in the federal government's effort to update regulation in this emerging industry, we seek to work with California and any other state in their processes,” Baker said.

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