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FDA Halts Consumer-direct DNA Test

The U.S. Food and Drug Administration is ordering genetic test maker 23andMe to halt sales of its [$99] personalized DNA test kits.

WASHINGTON (AP) - The Food and Drug Administration has ordered Google-backed genetic test maker 23andMe to halt sales of its personalized DNA test kits, saying the company has failed to show that the technology is supported by science.

In a warning letter posted online Monday, FDA regulators say that the Silicon Valley firm has not shown that its tests are safe or effective despite "more than 14 face-to-face and teleconference meetings" and "hundreds of e-mail exchanges." The agency orders 23andMe to stop marketing its test immediately, warning that erroneous results could cause customers to seek unnecessary or ineffective medical care.

23andMe's saliva-based test kit, launched more than 5 years ago, claims to tell customers if they are at risk for more than 250 diseases and health conditions. The FDA says only medical tests that have been cleared by the government are permitted to make such claims.

read rest here: http://www.usatoday.com/story/news/nation/2013/11/25/23andme...

FDA letter here:
http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2...

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Asclepius's picture

I like the "Bio-Hacking" business model

because it puts the consumer in control of their own testing results and bypasses the Medical Establishment.

Its also a great libertarian business model for small biotech start-ups and many companies are trying to go consumer direct in what is known as "Bio-Hacking." I recall seeing one on Kick Start not long ago.

Hopefully, the FDA's decision to stop 23andme is a legitimate concern about whether "the firm has analytically or clinically validated its technology" and not an attempt to prevent people from having more power over their own health.

Emancipate yourselves from mental slavery; none but ourselves can free our minds. - Bob Marley