Results 1 to 3 of 3

Thread: FDA Bloom SyndromeTest Approval

  1. #1
    Registered Users
    Sussex, UK
    Welsh, Scottish, Irish
    Y-DNA (P)
    mtDNA (M)

    United Kingdom Wales Scotland Ireland

    FDA Bloom SyndromeTest Approval

    BBC News - 20 Feb 2015:

    A Californian start-up will be allowed to advertise a mail order DNA test that screens for a rare genetic condition, after a U-turn by the US regulator.

    The Food and Drug Administration (FDA), said the 23andMe product would "provide people with information about possible mutations in their genes that could be passed on to their children".

    It had previously banned similar tests.

    The 23andMe kit screens for Bloom syndrome, an inherited disease that is most common among Ashkenazi Jews.

    It can detect whether a healthy person is a carrier of the genetic variant that causes the disorder, and therefore at risk of passing it on to their offspring.

    (continues ... )



    23andMe blog:


  2. The Following User Says Thank You to Caburn For This Useful Post:

     Joe B (02-21-2015)

  3. #2
    Registered Users
    mtDNA (M)

    United States of America
    A Californian start-up
    23andme's been around since 2007/2008. What classifies as a start up? In reference to the crux of the article, it really is a turn-around in thinking from the FDA:

    In a statement, the FDA also said it would provide the "least burdensome regulatory path" for future projects from 23andMe and similar companies.

    "In many circumstances it is not necessary for consumers to go through a licensed practitioner to have direct access to their personal genetic information," the regulator added.
    Why the shift, I wonder?

  4. #3
    Y-DNA (P)

    Ireland Germany England Netherlands Switzerland Scotland
    My sense is that this is really not a shift or turn around by the FDA. It is simply a matter of 23andme now being in compliance with regulatory requirements. Previously, 23andme was advertising a medical service which had not been reviewed and approved by the FDA. 23andme had apparently not followed the required process to gain approval before providing such a service. Since then, the FDA has worked with 23andme to help bring them into compliance with the regulatory process. The issue was not that these DNA tests had been outright banned, but simply that they had not yet been reviewed and approved by the FDA. 23andme was prohibited from offering such products until this situation was remedied.

  5. The Following User Says Thank You to miiser For This Useful Post:

     Joe B (02-21-2015)

Similar Threads

  1. Death Valley Super Bloom
    By Baltimore1937 in forum Flora
    Replies: 8
    Last Post: 06-14-2019, 11:13 AM
  2. Replies: 0
    Last Post: 04-08-2016, 03:18 PM

Posting Permissions

  • You may not post new threads
  • You may not post replies
  • You may not post attachments
  • You may not edit your posts