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DNA Helix

FDA sends letters to 5 genetic testing companies

It appears that the FDA sent letters to several different direct to consumer genetic testing companies. They are 23andme, Navigenics, DeCode, Illumina, and Knome, which provides whole genome sequencing. The FDA is claiming the tests must undergo approval as a medical device, but did not say anything about removing them from the market. The article also mentions that Pathway Genomics, the company producing the genetics tests that Walgreens considered selling in its stores, also received a letter.

Having recently received my 23andme results, I’m a little concerned by this statement:

Concern about the tests was also raised this week when 23andMe said that because of a laboratory mix-up, up to 96 customers might have received genetic information belonging to someone else.

I certainly hoped that they notified these customers of the potential error…

8 Comments

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  3. Genetic Alliance said,
    April 26, 2012 @ 12:34 pm

    I think its a good decision by FBI. If anythings happens due to this,then they will be held responsible.So,I think they should do these testing.

  4. Biology Guild said,
    June 17, 2012 @ 8:48 am

    The FDA did a good thing by sending the letters. The mistake by 23andMe is terrible.

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  7. Doug said,
    September 28, 2012 @ 9:11 am

    I have mixed feelings. It would seem that the mistakes of 23andme would require such notification from the FDA. MOst of the companies that do clinical work are required to follow certain standards and certifications. On the other hand, I also think the FDA tends to be a little overzealous. It is hard to tell in this case.

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    November 14, 2012 @ 9:51 pm

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