Genetic testing companies under investigation

In an article in April 24's San Jose Mercury News, author Steve Johnson reports that "New York authorities are scrutinizing at least two Bay Area [California] companies offering consumers genetic tests, and California health officials have at least six gene-testing companies under investigation."

At issue in New York are regulations that require a clinical laboratory permit for specimens. Here are some more details:

Jeffrey Hammond, a spokesman for the New York agency, said a total of 26 such letters have been sent to companies and organizations in various states offering genetic testing services. For typically $2,500 or less, such tests purportedly can detect everything from the identity of a baby's father to whether the person checked is at risk of developing a serious disease.

"Our concerns are about patient safety," he said. "These online tests raise the question, 'What will patients do with this information and is the information accurate?' "

He added that his department fears some people may use the genetic tests to "expose themselves to unnecessary medical treatments."

The article identified the two nationally known companies, both located in California, but did not identify the six companies being investigated by California officials. The department of health there "has been looking into the companies' operations because of a dozen consumer complaints it has received about such tests in the past year." A spokesperson for the department said that "the complaints center on the cost and accuracy of the tests, as well as on the issue of whether the tests have been ordered by licensed doctors, as is required by state law."

Besides the suits against a New Jersey company offering to determine the gender of a fetus from a sample of the mother's blood, these are the only cases I have seen so far of legal investigations into genetic testing companies. But, I'm sure we'll hear about more of these in the future.

Marie Godfrey, PhD

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