June 17, 2008

Genetic Testing Companies Under Scrutiny

The California Department of Public Health has called for makers of at-home genetic testing supplies to halt production due to consumer complaints about the tests' accuracy and cost.

Redwood Shores-based Navigenics Inc. and Mountain View-based 23andMe Inc. confirmed receiving the cease-and-desist letters.

Navigenics charges $2,500 to screen nearly 2 million genetic markers in a DNA sample - typically a swab of saliva - for potential health risks.

In a statement released Monday, Navigenics said it believed it was in full compliance with California law. The company said it would submit details to regulators showing its labs were certified and its tests are ordered and reviewed by California-licensed physicians.

Most of those in question are Web-based companies that provide services to scan customers' genes to spot potential health risks, from cancer to lower back pain.

Officials said all companies would have two weeks to show regulators that their laboratories were certified by the state and federal governments, said department spokeswoman Lea Brooks.

"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 that don't comply with the order will face fines of up to $3,000 a day.

A similar order was placed in New York State when Department of Health officials issued notices to about two dozen genetic testing companies in April.

State and federal officials insist that consumers must be skeptical, since genetic testing is only in the early stages, and doctors have received little training in evaluating and interpreting the results.

The federal Food and Drug Administration does not evaluate the tests for accuracy, though a federal panel recently recommended stepped-up oversight to ensure their validity.

A spokeswoman for 23andMe, which has financial backing from Google Inc. and Genentech Inc., described the company as an "informational service."

"What we do is offer people information about their genetic makeup, including ancestry and applicable scientific research," spokeswoman Rachel Cohen said. The company scans customers' DNA for about $1,000. Cohen declined to say Monday whether 23andMe had halted sales in California.


On the Net:

California Department of Public Health

Navigenics Inc.

23andMe Inc.