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Old 06-18-2008, 08:26 AM #1
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Lightbulb Gene Testing -California Orders To Stop Gene Testing!

Gene Testing
California Orders Stop To Gene Testing
Robert Langreth, 06.14.08, 10:30 AM ET

California becomes the second big state to crack down on companies that offer gene tests to consumers via the Web. This week, the state health department sent cease-and-desist letters to 13 such firms, ordering them to immediately stop offering genetic tests to state residents.

The state won't identify which companies were mailed letters until it confirms those firms have received them. But high-profile gene testing companies that operate in California include 23andMe, founded by the wife of a top Google billionaire, and Navigenics, based in Redwood Shores.

Both companies use DNA chips to scan a person's genome for gene variants that can be used to predict increased risk of developing a wide variety of diseases. DeCode Genetics of Iceland offers a similar consumer test.

23andme did not immediately return calls Friday afternoon. Navigenics confirmed it had received a letter. Navigenics Chief Executive Mari Baker said her company continues to process orders from California residents because "to the best of our knowledge, we are in compliance" with state law. Navigenics uses a doctor to transit orders and review results, and it relies on a state-certified lab testing company to do the gene tests, Baker said.

One controversy is that some gene testing Web sites take orders directly from patients without a doctor's involvement. (Navigenics says it uses a doctor.) California law requires that a licensed physician order any lab tests, including genetic tests, says Karen Nickel, chief of laboratory field services for the California Department of Public Health. All lab tests must also be validated for accuracy and medical utility, according to state requirements, Nickel says.

"These businesses are apparently operating without a clinical laboratory license in California. The genetic tests have not been validated for clinical utility and accuracy," says Nickel. "And they are scaring a lot of people to death."

Requiring that such tests demonstrate clinical "utility" could pose a particular problem if applied to 23andMe: The company has admitted its tests are not medically useful, as they represent preliminary findings, and so are merely for educational purposes.

California's move follows a crackdown on online gene testing firms by the state of New York, which sent warning letters to a number of firms, including 23andMe and Navigenics. California said its investigation followed a number of consumer complaints. "The consumers were unhappy about the accuracy [of the tests] and thought they cost too much," a spokeswoman for the department said.

Also See:

Special Report: Stem Cells Get Real
Fixing Pharma
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