4 ms·

It seems to be endemic to these biotech darlings: 23 & Me pulled the same thing and faced the same consequence. They thought as a tech prima donna that they did

It seems to be endemic to these biotech darlings: 23 & Me pulled the same thing and faced the same consequence. They thought as a tech prima donna that they did not have to adhere to the FDAs medical device regulations (or even publish efficacy data). They got smacked in the mouth - serves them right.

CamperBob2 11y ago
23 & Me's tests worked, though. And it's possible for a reasonable person to believe that the regulations they violated are BS. Their actions were arguably no more inherently immoral than Uber's "disruption" of the taxi incumbents and their captive regulators. This isn't the same thing at all.
- dfsegoat 11y ago
  The ignorance of, and/or disregard for regulatory standards is the common thread here. Also, How do you know they work? They got slapped for giving people risks of disease using genetic data over the internet -- a method which was not peer-reviewed or shown to be accurate and precise. That is not bullshit - that is effective regulation. The saddest thing is - even if you are right, all the FDA asked 23&Me to do was file a premarketing authorization -- something that many tiny companies do all the time to buy time to generate solid evidence.
  - mattmcknight 11y ago
    "They got slapped for giving people risks of disease using genetic data over the internet -- a method which was not peer-reviewed or shown to be accurate and precise." So if they delivered the results by mail or phone call they would have been in the clear? That is bullshit.
    - dfsegoat 11y ago
      Nope. It doesn't matter if the results came by courier pigeon: The test has not been validated in controlled trials or even published in peer-reviewed literature -- let alone approved by the FDA. If it were so simple don't you think they would have obtained approval by now? The sad thing is any idiot can invent a glucose meter and file their PMA properly -- but a company essentially backed by Google blows it horribly.
wbl 11y ago
23&Me was presenting patients with studies based on genes they actually found in the samples. They got busted because the studies weren't clinical trials done by the FDA. I've got a rare genetic disease for which there is no FDA approved test: too few patients, and it's 100% penetrant, so the geneticist just looked at the sequence. 23 & Me wasn't so different from that.
- dfsegoat 11y ago
  Taking your sequence data to a counselor is a solid use of 23&Me data. RE: risk prediction - they need to show efficacy & describe methodology in a clinical trial. Otherwise one is just taking their word for it that your risk is what they say it is -- or that they didn't mix up your sample/lose chain of custody.

CamperBob2 11y ago

23 & Me's tests worked, though. And it's possible for a reasonable person to believe that the regulations they violated are BS. Their actions were arguably no more inherently immoral than Uber's "disruption" of the taxi incumbents and their captive regulators. This isn't the same thing at all.

dfsegoat 11y ago
The ignorance of, and/or disregard for regulatory standards is the common thread here. Also, How do you know they work? They got slapped for giving people risks of disease using genetic data over the internet -- a method which was not peer-reviewed or shown to be accurate and precise. That is not bullshit - that is effective regulation. The saddest thing is - even if you are right, all the FDA asked 23&Me to do was file a premarketing authorization -- something that many tiny companies do all the time to buy time to generate solid evidence.
- mattmcknight 11y ago
  "They got slapped for giving people risks of disease using genetic data over the internet -- a method which was not peer-reviewed or shown to be accurate and precise." So if they delivered the results by mail or phone call they would have been in the clear? That is bullshit.
  - dfsegoat 11y ago
    Nope. It doesn't matter if the results came by courier pigeon: The test has not been validated in controlled trials or even published in peer-reviewed literature -- let alone approved by the FDA. If it were so simple don't you think they would have obtained approval by now? The sad thing is any idiot can invent a glucose meter and file their PMA properly -- but a company essentially backed by Google blows it horribly.

wbl 11y ago

23&Me was presenting patients with studies based on genes they actually found in the samples. They got busted because the studies weren't clinical trials done by the FDA. I've got a rare genetic disease for which there is no FDA approved test: too few patients, and it's 100% penetrant, so the geneticist just looked at the sequence. 23 & Me wasn't so different from that.

dfsegoat 11y ago
Taking your sequence data to a counselor is a solid use of 23&Me data. RE: risk prediction - they need to show efficacy & describe methodology in a clinical trial. Otherwise one is just taking their word for it that your risk is what they say it is -- or that they didn't mix up your sample/lose chain of custody.