TRENDS & PERSPECTIVES
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Two of the most populous states in the U.S. have sent warning shots to companies offering genetic testing services via the Internet. The companies have been warned that they are not complying with state laws and that they must take certain actions to demonstrate their compliance.
In June, the California Department of Public Health issued notices to 13 companies to cease and desist performing genetic testing for California residents until they meet the requirements specified in state law. According to public health department officials, any business offering genetic tests to California residents must be licensed as a clinical laboratory in California and must have a federal certificate for laboratory testing under the Clinical Laboratory Improvement Amendments (CLIA). In addition, all genetic tests must be ordered by a licensed physician.
Under the cease-and-desist order, the companies have been directed to submit a plan of correction to the department within 14 days from the date the orders were mailed. Each correction plan needs to either convince the department that they are operating within the law or show how they are going to come into compliance with California laboratory law. The companies were also directed to provide the department with validation documents to verify test performance and the specifications of all genetic tests.
“A company that does genetic testing needs to be certified and licensed for high-complexity testing, and has to validate its genetic tests,” says Lea Brooks, a spokesperson for the California Department of Public Health. “So until a facility or business is licensed, any advertising for genetic services, whether through printed material or the Internet, must clearly state that this testing is prohibited for California residents.”
The 13 companies that received the cease-and-desist notices were the following: CGC Genetics (Porto, Portugal), deCODEme Genetics (Reykjavik, Iceland), DNA Traits (Houston, TX), Gene Essence (San Jose, CA), HairDX LLC (Irvine, CA), Knome (Cambridge, MA), Navigenics (Redwood Shores, CA), New Hope Medical (Henderson, NV), Salugen (San Diego, CA), Sciona Inc. (Aurora, CO), Smart Genetics (Philadelphia, PA), Suracell Inc. (Livingston, NJ), and 23andMe (Mountain View, CA).
Brooks added that businesses that fail to comply with the cease-and-desist order are subject to civil and criminal sanctions as allowed by law. The health department can issue fines to companies performing genetic tests without a license. Such companies may be referred to the district attorney for criminal prosecution.
To a certain extent, California public health officials may have taken a cue from their counterparts in New York. “We were very aware of what New York was doing,” says Brooks. “So what we did was a combination of the consumer complaints we received, our own awareness, and New York’s actions.”
Last November, the New York State Department of Health sent letters to several companies offering online genetic testing, warning them that they were violating several public health laws. The warning letters informed the companies that they were prohibited from accepting specimens originating from New York without the requisite clinical laboratory permit. Since November, the department has sent such letters to 26 companies. Two of the companies that received letters from New York include 23andMe and Navigenics.
According to health department officials, once the letters were sent out, the companies were considered to have been put on notice. If it is found out later on that the companies have not taken any appropriate actions and continue to operate in New York, the department would then move toward an enforcement action. Such enforcement actions could be levying fines, imprisonment, or both.
“But for the most part, once the companies received the letters, they have contacted the department and initiated discussions to find out how they can come into compliance,” says Jeffrey Hammond, a spokesman for the New York State Department of Health. “Some organizations that have received the letters have decided they are not willing to go through the mechanics of applying for the licensing and the certification, so they have opted not to operate in New York.”
