Five of 13 gene testing businesses ordered two weeks ago by California health authorities to halt operations until they prove they are complying with the law are based in California, according to a list those authorities made public Tuesday.
The letters from the California Department of Public Health had told the companies to stop conducting tests involving biological specimens originating from California until the companies obtained clinical laboratory licenses or registrations. The letters also required the companies to ensure that doctors ordered the genetic tests.
Executives at Navigenics of Redwood City and 23andMe of Mountain View, which previously had acknowledged receiving the cease and desist letter, contend they have been operating lawfully because they already use certified labs and have doctors order their tests.
The other California companies that were sent letters are Gene Essence of San Jose, HairDX of Irvine and Salugen of San Diego.
A person who declined to identify herself and who answered the phone at the number listed on Gene Essence’s Web site said she didn’t know anything about that business or Robert Danielzadeh, identified by the state as its chief executive.
Jon Boroshok, HairDX’s spokesman, said that the company several days ago stopped selling its services to residents of California and New York, which also has sent letters to genetic testing companies raising concerns about their operations. He said HairDX is continuing to sell its tests for determining susceptibility to hair loss to people in other states.
No one could be reached for comment at Salugen.
Other companies sent letters were DNA Traits of Houston; Knome of Cambridge, Mass.; New Hope Medical of Henderson, Nev.; Sciona of Aurora, Colo.; Suracell of Livingston, N.J.; Smart Genetics of Philadelphia; CGC Genetics of Portugal; and deCODEme Genetics of Reykjavik, Iceland.
Lea Brooks, spokeswoman for the California Department of Public Health, said the state will need to verify that the companies’ laboratories comply with all relevant laws before allowing the businesses to test other California consumers. She wasn’t sure how long that might take.
Contact Steve Johnson at sjohnson@mercurynews.com or (408) 920-5043.
