Genetic testing under fire

As I reported a month or two ago, some genetic testing firms have been receiving letters from some state officials telling the firms to prove they meet the state requirements for genetic testing or stop accepting test kits from residents. At first, it was only New York. Now, California has joined the fray. Although neither state agency will identify to whom the letters were sent, newspaper writers have been calling around to see if they can identify the perpetrators.

Most of the reports are based on a release from the Associated Press, which includes the following:

California health regulators have demanded that 13 direct-to-consumer genetic testing startups halt sales in the state until they prove they meet state standards.

The state Department of Public Health sent the cease-and-desist letters last week following an investigation spurred by consumer complaints about the tests' accuracy and cost, a department spokeswoman said Monday.

Two of the most visible companies to offer consumer genetic tests — Redwood Shores-based Navigenics Inc. and Mountain View-based 23andMe Inc. — confirmed receiving the letters.

Health officials would not identify the companies involved until confirming they had received the letters but said all the targeted companies advertise on the Internet.

All the companies have two weeks to demonstrate to regulators that their laboratories are certified by the state and federal governments, said department spokeswoman Lea Brooks. The startups also must show the tests they are selling California residents have been ordered by a doctor as required by state law.

"There's either concern they don't have a license, there isn't a physician's order, or both," Brooks said. "That's what's under investigation."

Companies face fines of up to $3,000 a day.

What's important here to residents of other states is that the investigations in New York and California into genetic testing companies were prompted by customer complaints.

Makes me wonder what those complaints were.

Marie Godfrey, PhD

 

 

 

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