Genetic Future

GenomeWeb reports that the advocacy group Genetic Alliance is lobbying the FDA for the construction of a public registry of genetic tests:

[Genetic Alliance Director of Genetics and Health Policy Kristi] Zonno said FDA should create a public registry for genetic tests to “enable transparency and promote informed decision making for consumers and providers.” She said that registry “could and should include the myriad of genetic, genomic, and pharmacogenomic testing available to the US market.”

Open to the public, the registry should at the very least include the name of the lab performing a test, the name of the test developer, and information to support the test’s usefulness in obtaining results and improving clinical care, Zonno added.

This move is long overdue – there have been discussions of the need for such a database in many circles for well over a year, but there has been no visible progress yet. This is an enormously complex industry, and consumers need guidance from independent bodies (certainly more than they need over-zealous regulation of the industry). If Genetic Alliance can convince FDA to make a real effort here that would be a major step in the right direction.

Comments

  1. #1 Steven Murphy MD
    June 24, 2009

    Daniel,
    This is huge and should keep the marketing idiots from inferring that you can use a 23andMe test to rule out CF carrier state!

    I am so sick of marketing and business people monkeying this whole field up!

    Steve

  2. #2 Chaim
    June 25, 2009

    what about genetests.org?

  3. #3 Daniel MacArthur
    June 25, 2009

    Hi Chaim,

    Off the top of my head: GeneTests has an almost entirely clinical focus, doesn’t cover most recreational tests or genome scans, doesn’t provide independent reviews of the validity of tests, and doesn’t provide information in a format that’s easy for a consumer to understand.

  4. #4 anomalous
    June 25, 2009

    The venture caps would love state mandated barriers to entry on this is. Can’t let those pesky garage entrepreneurs do it with credit cards and Ramen noodles.

    The free market obviously does not work and it’s clear that Nancy Pelosi, John McCain and Barney Frank need to protect us.

    Just like they did with TARP.

    Seriously, folks, who are the “genetic alliance” dudes? Sounds like some industry lobbying group; i.e. keep your hand on your wallet.

  5. #5 Daniel MacArthur
    June 26, 2009

    anomalous,

    Right – so having to add “the name of the lab performing a test, the name of the test developer, and information to support the test’s usefulness in obtaining results and improving clinical care” to a database is an unfair barrier to market entry for a genetic test provider claiming to provide health benefits?

    Come on. I agree that over-the-top regulations (e.g. barring a company from a offering a test unless it meets requirements for clinical validity) would be counter-productive, but providing accurate information to consumers to enable them to make a sound decision in a complex area is a Good Thing.

  6. #6 anomalous
    June 26, 2009

    There is NO need for a government approved list at this time.

    Unless “Genetic Alliance” discloses its sponsors, then I’m assuming it’s another industry lobbying group doing what they do : spinning the public relations and buying protection.

    Yes, they’d love to have government approval for their competitors. “Just fill out this 40 page questionnaire and we’ll get back to you with a decision”.

    Where’s the evidence that we NEED this at this time ?

  7. #7 Genetic Alliance Staff
    June 30, 2009

    Hello ‘anomalous’,

    Genetic Alliance is a 501 (c)(3) not-for-profit health advocacy organization. We were founded in 1986 as the Alliance for Genetic Support Groups, and are committed to transforming health through genetics. Our open network connects members of parent and family groups, community organizations, disease-specific advocacy organizations, professional societies, educational institutions, corporations, and government agencies to create novel partnerships. We actively engage in improving access to information for individuals, families and communities, while supporting the translation of research into services. We promote an environment of openness centered on the health of individuals, families, and communities. Openness forms both the process and product for Genetic Alliance.

    Please visit our website at http://www.geneticalliance.org or email us at info@geneticalliance.org to find out more about our mission and goals.

  8. #8 anomalous
    June 30, 2009

    GeneticAllianceStaff,
    I’m glad your committed to open-ness. What percentage of you funding comes from corporations involved in biotech?

  9. #9 GeneticAllianceStaff
    July 2, 2009

    Anomalous,

    Less than 5% of Genetic Alliance’s funding is from biotech/pharma. Please visit http://www.geneticalliance.org for more information.

  10. #10 anomalous
    July 6, 2009

    GeneticAlliance Staff.
    How about a specific URL? not the front page.