For samintx: FDA halts sales of 23andMe DNA test kits

[Dennis S]

There was a thread a few weeks ago about the 23andMe $99 DNA test.

http://www.usatoday.com/story/news/natio...e/3699329/#

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.

http://forums.macresource.com/read.php?1...sg-1627447

[Janit]

Dennis S wrote:
There was a thread a few weeks ago about the 23andMe $99 DNA test.

http://www.usatoday.com/story/news/natio...e/3699329/#

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.

http://forums.macresource.com/read.php?1...sg-1627447

Not quite accurate. The FDA has asked 23andme to stop marketing the tests for medical-related purposes as there are questions about how these tests will be used and the accuracy/implications of the medical-related information provided. This is actually a thorny issue, and it is not a surprise that the company has had difficulty formulating answers to the FDA's questions.

Marketing for genealogical purposes is still OK.

[PeterB]

Janit wrote:
[quote=Dennis S]
There was a thread a few weeks ago about the 23andMe $99 DNA test.

http://www.usatoday.com/story/news/natio...e/3699329/#

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.

http://forums.macresource.com/read.php?1...sg-1627447

Not quite accurate. The FDA has asked 23andme to stop marketing the tests for medical-related purposes as there are questions about how these tests will be used and the accuracy/implications of the medical-related information provided. This is actually a thorny issue, and it is not a surprise that the company has had difficulty formulating answers to the FDA's questions.

Marketing for genealogical purposes is still OK.
Yes, but even marketing for genealogical reasons is potentially disingenuous, and might come under scrutiny by the FTC (rather than the FDA). If the technology isn't really supported by the science, then I don't see how it's any more useful for that-- unless you're talking about things like paternity testing, but there had already been ways to do that before 23andme came along.