Thursday, June 19, 2008

Will California's Letters to Genetic Testing Companies Affect Genealogists?

Posted by Diane

California's attempt to regulate genetic testing has raised a bit of a stir in the genealogical community, but it's unclear whether genetic genealogy tests will be affected.

Wired reports that the state department of public health sent sternly worded cease-and-desist letters to 13 DNA testing companies warning they’re in violation of California law.

California requires labs that are located in the state or process biological samples originating there to get a state laboratory license, and it also prohibits direct-to-consumer clinical lab tests without a doctor’s order.

One warning letter, linked in Wired’s article, specifically states genetic tests are not exempt. But it doesn’t distinguish between genetic genealogy tests (such as Y-DNA tests) and disease-related genetic tests (such as 23andMe’s genotyping services).

Genetic genealogy company FamilyTreeDNA didn’t receive a letter, spokesperson Bennett Greenspan told me, but the company’s disease-related testing business called DNA Traits got one (now posted on Wired). And from the letter's wording, it looks like the state’s concern is tests that reveal medical information without involving the consumer’s physician.

The California Department of Health hasn’t yet returned my call seeking clarification. Meanwhile, the letter demands recipients cease and desist offering genetics tests to California citizens.

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