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URGENT Advice re. FDA's 15-Day Letter to 23andMe

12/4/2013

 
  • If you have had DNA testing at 23andMe, it is important that you are aware that the US Food and Drug Administration  (FDA) has issued a 15-day "cease and desist" letter. The implications for 23andMe and its customers are unknown.
  • It is important that you realize that there is the potential that access to your DNA data may be removed (either by the regulatory clout of the FDA or by 23andMe) by 13 December 2013 or 16/17 December 2013 (depending on whether US Thanksgiving holiday is included or excluded as a business day).
  • Although FDA doesn't give two hoots about genetic genealogy data, they have a huge issue with the health information that 23andMe provides "because it is intended for use in the diagnosis of disease or other conditions or in the cure, mitigation, treatment, or prevention of disease".
  • I have outlined some information about this and offered some advice for important steps I will be taking, and also advising others to take at http://www.genealogyjunkie.net/urgent-advice-re-fdas-15-day-letter-to-23andme.html. I can't stress this enough. Whether you are primarily interested in the genealogy aspects or the health aspects of 23andMe, you absolutely MUST download your raw DNA data. Click Here for the 23andMe link to do this. Detailed instructions and screenshots are provided Here.
  • At the moment, it's rather like preparing for a potential earthquake or hurricane – but it's better for all of this be unnecessary, rather than looking back and regretting you didn't take some preparatory steps.
  • Please forward this information (or This Blog Posting or Webpage) on to others who have tested at 23andMe, to make them aware.
23andMe Blog Posting 26 Nov 2013
23andMe Blog Posting, 26 November 2013
27andMe E-mail to Customers 27 Nov 2013
23andMe Letter from CEO sent on Wednesday, 27 November 2013
  • 23andMe posted something on their blog about this on 26 Nov 2013 and their CEO, Anne Wojcicki, sent an e-mail to to 23andMe customers on 27 Nov 2013, indicating that updates would be posted on the 23andMe Blog (see above). As of 4 Dec2013, as far as I'm aware, 23andMe has not issued any updates.
UPDATE: See Blog Posting of 7 Dec 2013 (23andMe Update: No Health Reports for New Customers)

What's New on GenealogyJunkie.net?

  • I wrote a Blog Posting (dated 26 November 2013) on my Dad's best friend from school, Gordon Sproat, who was killed in World War II, in the hope that some of his relatives comes across it  and then have access to some information and photos.
  • I'm still  encouraging everyone to order DNA tests during Family Tree DNA's Great Sale, which is on until 31 Dec 2013. Now is a wonderful time to order a test or upgrade testing – or maybe this could be a holiday gift idea.

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