NEW YORK (GenomeWeb News) – The New York State Department of Health has sent warning letters to 23 firms involved in offering consumer genomics services and genetic tests to consumers, telling them that they need a permit to offer such tests and services, a department spokesperson told GenomeWeb Daily News today.
Among the firms that were sent letters were Navigenics, 23andMe, Affymetrix, Illumina, and HairDx. Iceland's DeCode Genetics, which offers a consumer genomics service and has been offering the test to New York state residents, has not received a letter from the state.
According to an article on Forbes.com published on Friday, New York officials were not aware that DeCode was selling its services to New York residents. The department of health spokesperson could not confirm whether DeCode is among the 23 firms that were sent letters.
It is unclear why Illumina and Affymetrix, which are supplying the instrument platforms used to genotype consumers but are not marketing the services themselves, are considered to be violating New York State law. Affymetrix provides lab services for the Navigenics offering via its CLIA-certified laboratory in Sacramento, Calif.
State health officials consider the consumer genomics services to be offering medical tests, which under New York State law would make them subject to medical testing regulations. As such, the firms would need to obtain a permit for offering genetic tests in the state and the tests would have to include a doctor’s order, according to the spokesperson.
She added that the state's attorney general would be notified of firms who continue to offer their services to New York State residents without the proper permit and involvement of a physician.
The consumer genomics firms have countered that the services they offer are meant to be educational, not medical.
DeCode and 23andMe launched their services, which cost around $1,000, around the same time last November. The services use a DNA sample taken from a consumer’s saliva or a cheek swab, and using genotyping tools provide consumers with information about genetic variants associated with risks for common diseases, ancestry, and traits such as hair and eye color.
DeCode CEO Kari Stefansson emphasized at the time of the firm’s launch of the DeCodeMe service that it is not offering a genetic test. “We strongly encourage you not use this to make medical decisions,” he said during a webcast. “If there is something that raises concerns when you look at your result … you can ask a question that will be answered by our experts.” The firm may also refer subscribers to a genetic counselor, he added.
Illumina is providing the genotyping platform and chips for 23andMe’s service, and even though several media outlets have reported that DeCode is using Illumina’s technology for its service as well, DeCode has never publicly verified those reports.
Navigenics, another consumer genomics services firm that is using Affymetrix’s genotyping tools for its offering, officially launched last week. It had previously said that it would offer its services for around $2,500.
In addition to these companies, SeqWright and GATC Biotech have also jumped into the consumer genomics ring, and Knome offers a whole-genome scan for the very high price of roughly $350,000.
The rapid proliferation of these consumer genomics services has brought questions about whether the US Food and Drug Administration will regulate them as genetic tests as well as concerns about keeping data private.
An opinion piece in the New England Journal of Medicine in January called the consumer genomics services “premature attempts at popularizing genetic testing.” The authors of the op-ed includes Muin Khoury, director of the National Office of Public Health Genomics at the US Centers for Disease Control and Prevention; David Hunter, a professor of epidemiology and nutrition at the Brigham and Women’s Hospital at Harvard Medical School; and Jeffrey Drazen, an environmental health professor at Harvard who also serves as NEJM’s Editor-in-Chief.
They argued that the medical field and the public will not be ready to deal with the implications of consumer genomics until more translational medicine connects information from the vast amount of genome-wide association data to personal genomes in meaningful ways.
Against this backdrop, legislation is pending in Congress to protect Americans from genetic discrimination from insurance companies and employers, and some see quick passage of this legislation as crucial as more consumers gain access to their own genetic information.