FDA vs 23andMe: Link Round Up

What a difference a year has made for 23andMe. For the last Thanksgiving 23andMe was busy surprising the users visiting 23andMe site randomly by lowering the 23andMe kit price randomly (to as low as $49). Remember, then 23andMe kit costed $299. And by the second week of December, 23andMe raised $50M in funding and dropped the kit price to $99 from $299 for good.

In contrast, just as you are waiting on how low 23andMe kit price can go, FDA dropped the bombshell and showed us all how low the whole of 23andMe can go. In stern words, FDA asked 23andMe to “discontinue marketing the PGS”, raised multiple issues with 23andMe’s practice and gave 15 working days to get back to FDA with all the corrective actions or the timeframe to complete the corrective actions.

FDA’s action has raised a lot interesting questions on 23andMe’s future, 23andMe’s operation and the future of personal genetics market. In the last couple of days, a lot of interesting commentaries have been written on FDA vs 23andMe. Here is the collection of all the interesting articles. No doubt, the collection is an awesome “long read” for the thanksgiving break.

  1. FDA’s warning letter to 23andMe
  2. 23andMe’s First response to FDA
  3. 23andMe’s second response by 23andMe’s CEO Anne Wojcicki 
  4. Stanford Law School: The FDA drops an anvil on 23andMe – NOW WHAT?
  5. Mathew Herper @ Forbes: 23andStupid: Is 23andMe Self Destructing? 
  6. Razib Khan @ Gene Expression: The FDA and 23andMe
  7. Razib Khan @ Slate: The FDA’s Battle With 23andMe Won’t Mean Anything in the Long Run
  8. David Dobbs Neuron Culture: FDA Muzzles 23andMe After Talks Break Down
  9. Mike Eisen: FDA vs. 23andMe: How do we want genetic testing to be regulated?
  10. NYTimes: F.D.A. Orders Genetic Testing Firm to Stop Selling DNA Analysis Service
  11. Boing Boing: FDA orders 23andMe, backed by Google, to halt sales of DNA test service
  12. The Guardian: FDA orders genetics company 23andMe to cease marketing of screening service
  13. Mike the Mad Biologist: Some Thoughts on the FDA Action Against 23andMe.com
  14. The Verge: Body blow: How 23andMe brought down the FDA’s wrath
  15. Brave Bosom: FDA B*TCHSLAP OF 23ANDME: A BRCA PREVIVOR’S PERSPECTIVE
  16. Scientific American: FDA Was Right to Block 23andMe
  17. Scientific American: 23andMe Is Terrifying, But Not for the Reasons the FDA Thinks
  18. Myraqa: How Soon is Immediately?
  19. TIME.com: Time Out: Behind the FDA’s Decision to Halt Direct to Consumer Genetic Testing
  20. Venture Beat: Why the FDA is targeting Google-backed 23andMe: Unnecessary MRIs, mastectomies
  21. Ryan Bradley @ Fortune: The curious case of 23andMe
  22. Dr. Jen Gunter: When 23andMe gives results that no one knows how to manage
  23. PLOS Blogs: Why 23andMe is Not for Me — Yet
  24. Chillmark Research: 23andMe vs the FDA: How did it come to this?
  25. Gene Values: A red letter day for consumer genomics
  26. Bloomberg Businessweek: Do Genetic Tests Need Doctors? FDA Defends Its Challenge to 23andMe
  27. Med City News: Six smart takes on the 23andMe FDA standoff
  28. 1EQ: What is next for Direct to Consumer Genetics
  29. Quartz: 23andMe revealed a condition it took my doctors six years to diagnose
  30. David Dobbs on New Yorker: The F.D.A. vs Personal genetic testing

Will keep updating more links on 23andMe-gate.

Comments

  1. Anyone who would take the results of a $99 test at face value and not question results is foolish. But it allows you to know what questions to ask. My recent 23AndMe results (thankfully received before things went downhill thanks to the FDA!) may have saved my life. And yes, I did question the results and was retested by medical professionals–but I never would have known to get tested without 23AndMe. http://larasgenealogy.blogspot.com/2013/11/how-genealogy-saved-or-significantly.html

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