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Minnesota Gene Pool Blog

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California Sends Warning Letter to Consumer Genetic Testing Firms

A wide array of consumer genetic testing products are available via the internet. New York was the first state to regulate its citizens' access to these products. It looks like California is poised to follow suit. Is this good for public health? Does it unnecessarily limit consumer choice and control? Or protect consumers from bogus and useless tests? And what are the best ways to balance consumer protection with the need for innovation? There is a wide spectrum of opinion about these issues. What do you think?

From GenomeWeb News on June 16,2008:

By a GenomeWeb staff reporter

NEW YORK (GenomeWeb News) – The State of California is trying to keep consumer genetic testing companies from offering their services to the state’s residents and last week sent letters to thirteen firms saying they are violating state law, California Department of Health spokesperson Lea Brooks told GenomeWeb Daily News today.

The state will not disclose the names of the firms to which it has sent letters, or which laws their services violate, until the companies in question verify with the state that they have received the warnings, Brooks said.

With the move to begin regulating consumer genomics companies in the state, California follows New York State, which less than two months ago warned 23 companies that they must have permits to offer their services to New Yorkers.

New York’s warning letter was a shot across the bow not only to new companies, such as Navigenics and 23andMe, that last year entered into the fledgling field of consumer genomics, but also to technology suppliers Affymetrix and Illumina, which make the tools the testing companies use.

Whether California is focusing on consumer genomic testing companies or if it has broadened its authority to include technology suppliers will not be known until the authorities release the names of the companies it is contacting. California authorities also have not said whether information has been referred to the state’s Attorney General for further action.

One offense that genetic testing companies could commit would be to sell their products to California citizens over the internet without the request or counsel of a doctor, California Department of Public Health official Karen Nickel told last week. Another problem, Nickel said, could be that the companies’ tests have not been validated for accuracy or for clinical utility, which is required under California law.

Concerns over marketing genomic data to consumers and assertions about the ability of tests to predict disease risk were sharply rendered in January by Muin Khoury, director of the National Office of Public Health Genomics at the US Centers for Disease Control and Prevention.

After publishing a critical op-ed in the New England Journal of Medicine with two other authors, Khoury told GWDN that consumer genomics as it is today should be considered “recreational genomics,� and that the field was premature and consumers were not ready to receive the “alphabet soup� of genomic information they were buying.

To Khoury and his fellow NEJM writers, the problem of how to show the clinical usefulness of these genomics offerings would prove to be the most critical.

“The bottom line here is that people are beginning to be concerned that there may be more harm than benefit,� Khoury said.

© Copyright 2008 GenomeWeb Daily News. All rights Reserved.

Posted by Kristin Oehlke on June 18, 2008 12:17 AM |


Currently in the United States, no regulations are in place for evaluating the accuracy and reliability of genetic testing. Most genetic tests developed by laboratories are categorized as services, which the Food and Drug Administration (FDA) does not regulate. Only a few states have established some regulatory guidelines.

Posted by: Jane Palmer | December 3, 2008 12:12 AM