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From Mary Kugler, R.N., Former About.com Guide to Rare Diseases

Genetic testing companies in California allowed to stay in business

Thursday August 21, 2008
The California Department of Public Health (CDPH) created some controversy in June 2008 when it sent "cease and desist" letters to 13 companies that offer genetic testing directly to consumers. The CDPH argued that the companies weren't laboratories and the genetic tests weren't ordered by a physician, both of which are required under state law. Two of the companies, Navigenics and 23andme, argued back that they use certified labs off-site. They both now meet the requirement for a doctor's order for the tests. Based on this, both companies have been allowed to stay in business.

In case you're wondering, this type of genetic testing company sends the consumer a saliva collection kit. The consumer mails back the saliva sample and the company analyzes it, looking at the genes for common conditions (no rare disorders). The company then develops a risk profile, meaning it tells the consumer whether or not he or she is at higher risk for developing a condition, for example breast cancer. The science isn't developed enough yet to tell you for sure whether or not you will develop a condition, and as you might guess, some conditions like heart disease depend on many factors (and most likely more than one gene is involved). This type of genetic testing is expensive: Navigenics charges $2,500 for its services and 23andme charges $999.

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