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California Names Companies Caught in Consumer Genomics Crackdown

NEW YORK (GenomeWeb News) – The California Department of Public Health has released the names of the 13 genetic testing companies that it has told to stop offering services in California, including several consumer genomics companies and other direct-to-consumer firms offering tests for particular conditions.
The state notified a number of companies last week that they must cease and desist from offering the tests to California residents. These companies violate state regulations that these tests must be ordered by a physician and that the labs running the tests must be licensed by California, according to CDPH.
Companies that have already confirmed that they have received letters include 23andMe, DNATraits, Navigenics, and DeCode Genetics. Other firms that have received the letters include Knome, which offers full genome scans at a pricey $350,000 a shot, and HairDx, which offers a genetic test to predict baldness.
Knome, which was co-founded by Harvard University geneticist George Church, aims to be a genomics equivalent of low-orbit space tourism flights by offering full genome scans to the wealthy first and developing the technology to bring the price down in the future.
Another company told to stop selling its services to Californians is Gene Essence, which uses an Affymetrix array to identify SNPs a customer has for certain conditions. New Hope Medical, also named by CDPH, is a clinic that provides “diagnostics and therapies not readily available in conventional medicine,” according to its website, and it offers genomic testing for between 12 and 25 SNPs linked to certain conditions for between $475 and $900.
Also included among the 13 firms are CGC Genetics, Salugen, Sciona, Smart Genetics, and Suracell.
Knome told GenomeWeb Daily News in a statement that it has not yet responded officially to California, but said it is seeking “an ongoing dialogue” with the state.
“Our clients have a physician involved throughout the entire process, allowing us to deliver a more robust analysis and ensuring that our clients are supported by a knowledgeable advocate,” the company said.
Knome did not respond directly to California’s charge that it is not in compliance with the state’s lab licensing regulation.
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