California challenges DNA test start-ups
California health regulators have dealt a blow to direct-to-consumer genetic testing start-ups by demanding that 13 companies halt sales in the state until they prove they have met quality and reliability standards.
The Department of Public Health sent the cease-and-desist letters last week, after an investigation spurred by consumer complaints about the tests’ accuracy and costs, a department spokeswoman said Monday.
The department said it would not identify the companies involved until it confirmed they had received the letters. It said they all advertised on the Internet. Two of the best-known companies to offer consumer genetic tests, Navigenics Inc. and 23andMe Inc., both confirmed receiving the letters.
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.
They must also show that the tests currently being sold to California residents have been ordered by a doctor, as required by state law.
Companies face fines of as much as $3,000 a day if they don’t comply.
The New York State Department of Health issued similar notices to nearly two dozen testing companies in April.
The crackdowns follow the launch of a batch of new DNA analysis services spawned by a deluge of recent genetic discoveries. The mostly Web-based services will scan customers’ genes to spot potential health risks, such as cancer and lower back problems.
But public health officials have urged consumers to be skeptical, pointing out that most of the research is in its earliest stages and that doctors have little training in interpreting the results.
The Food and Drug Administration does not evaluate the tests for accuracy, though a federal panel recently recommended stepped-up oversight to ensure their validity.