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Deadline for Personal Genomics Companies

Posted Jul 22 2008 8:23pm


State of New York has issues warning against Personal genomics companies , after they have received many complaints. Now the State of California Department of Helath (CDPH) is trying to keep consumer genetic testing companies from offering their services to the state’s residents and last week sent letters to 13 firms saying they are violating state law. The companies have time till today June 24 to respond to the notice. While New York State warned several companies that genome tests could not be performed on samples from New York residents without formal state approval.

CDPH requirements mandate that

  1. Any business offering genetic tests to California residents must be licensed as a clinical laboratory in California
  2. The laboratory must have must have a CLIA certificate for laboratory testing
  3. All genetic tests must be ordered by a licensed physician

The 3rd part of the requirements mean the end of DIY genetic testing and more headches for companies in coming weeks.

Google-backed23andMeandNavigenicsare also included in the list of companies that received the notice The major companies, including 23andMe, Navigenics, andDecode Geneticshave issued statements confirming that theya re using CLIA registered laboraotries for the testing DNA genotyping. 23andMe partners with Illumina, while Navigenics collaborates with Affymetrix.

Steven Murphycompared these companies to napster check out his blogpost1post2on this subjetcs. He is certainly not likely to be excited to learn that23andMe has launched a wiki page called 23andWeto recruit its customers to participate in studies trying to shed additional light on genetic predispositions for certain diseases and adverse drug reactions.

23andMe has maintained that it is not selling a medical service but rather giving people access totheir genetic information. They company prefers to call its 23andWe study participants“customers” and not “patients,” . Smart move butlets see if CDPH is going to buy that argument.

But today 23andMe shot back to CDPH that they’ll be doing neither cease nor desist. We believe we are in compliance with California law and are continuing to operate in California at this time,” the company said in astatement released to Wired.com

The company has has argued that the testing they provide isn’t a prevention aid, but merely offers “individuals contextual information about their genetic makeup, including ancestry and applicable scientific research.”

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