3 ms·

From what I understand, the test doesn't attempt to diagnose an existing condition. Instead, it shows whether you have a gene that indicates a predisposition to

From what I understand, the test doesn't attempt to diagnose an existing condition. Instead, it shows whether you have a gene that indicates a predisposition to the condition. In that case, prophylactic measures can be taken, once confirmed and if desired. This is what drove Angelina Jolie's decision to have a double-mastectomy. That's a hugely significant difference vs. actually being diagnosed with a life-threatening condition. I don't think people would commit suicide or become unduly despondent if they learned they have a gene. They would just know they need to take action, get further testing, be vigilant, etc. It's not much different (in spirit) from knowing that your family history predisposes you to a certain condition.

mbreese 13y ago
It's all about education and results reporting. Where you or I might see a result as a predisposition to a phenotype with a statistical probability, someone else might see a death sentence. That could be one area that the FDA might be trying to address.
- unclebucknasty 13y ago
  I agree that it has to be clearly reported and explained. But, you know, there are in-home HIV tests that are FDA-approved. They tend to stress professional counseling and/or follow-up testing, etc. They also explain such somewhat-technical details as the window between infection and antibody formation, so it's an education process there as well. But, I think the availability of such a test is testament to the fact that easier access to important knowledge re: one's status may be worth the risks.
  - mbreese 13y ago
    HIV tests are pretty simple, from a diagnostic test point of view. It's really a boolean - HIV present, or not present. The meaning of a particular genetic variant is much more ambiguous.
    - unclebucknasty 13y ago
      It's odd to me that you're saying HIV tests can give definitive devastating diagnoses to people alone in their homes, yet they are OK; but genetic testing provides a range of possibilities and recommends further investigation, but they are somehow so devastating that they would drive someone to despair or suicide.
      - mbreese 13y ago
        I'm not trying to equate things to HIV tests, and it's probably a poor example. I'm not sure what the reporting process for an in-home HIV test would be. I recently had a doctor tell me that she's not allowed to actually give the results of an HIV test over the phone for fear of patient reactions. What I was trying to say was that that class of test should be easier to use and get a definitive yes/no answer with a smaller false positive rate.
smackfu 13y ago
>I don't think people would commit suicide or become unduly despondent if they learned they have a gene. What if the gene essentially means "you and your husband shouldn't have children?"
- Dylan16807 13y ago
  They'd probably feel a hundred times worse if they found out by observing the symptoms in those future children.
- unclebucknasty 13y ago
  I think one can make a million hypothetical arguments against the testing. But, I just don't see people taking the test at face value and making major life decisions without further follow-up. I think most reasonable people would consider it a screen. If the testing was wildly inaccurate, then that's another issue. It almost becomes more an FTC consumer protection-type matter at that point. But, there is no indication that this is the problem. They go on to state that their testing is done in CLIA-certified laboratories: https://www.23andme.com/howitworks/ https://www.23andme.com/howitworks/ (near bottom of page) http://www.cms.gov/Regulations-and-Guidance/Legislation/CLIA/index.html?redirect=/clia/ http://www.cms.gov/Regulations-and-Guidance/Legislation/CLIA... BTW, I'm not really defending the service, per se. In fact, I have issues with it that are more along the privacy lines. I just don't see where there's any proof that it has an outsized chance of ruining lives any more than, say, in-home HIV testing.

mbreese 13y ago

It's all about education and results reporting. Where you or I might see a result as a predisposition to a phenotype with a statistical probability, someone else might see a death sentence. That could be one area that the FDA might be trying to address.

unclebucknasty 13y ago
I agree that it has to be clearly reported and explained. But, you know, there are in-home HIV tests that are FDA-approved. They tend to stress professional counseling and/or follow-up testing, etc. They also explain such somewhat-technical details as the window between infection and antibody formation, so it's an education process there as well. But, I think the availability of such a test is testament to the fact that easier access to important knowledge re: one's status may be worth the risks.
- mbreese 13y ago
  HIV tests are pretty simple, from a diagnostic test point of view. It's really a boolean - HIV present, or not present. The meaning of a particular genetic variant is much more ambiguous.
  - unclebucknasty 13y ago
    It's odd to me that you're saying HIV tests can give definitive devastating diagnoses to people alone in their homes, yet they are OK; but genetic testing provides a range of possibilities and recommends further investigation, but they are somehow so devastating that they would drive someone to despair or suicide.
    - mbreese 13y ago
      I'm not trying to equate things to HIV tests, and it's probably a poor example. I'm not sure what the reporting process for an in-home HIV test would be. I recently had a doctor tell me that she's not allowed to actually give the results of an HIV test over the phone for fear of patient reactions. What I was trying to say was that that class of test should be easier to use and get a definitive yes/no answer with a smaller false positive rate.

smackfu 13y ago

>I don't think people would commit suicide or become unduly despondent if they learned they have a gene. What if the gene essentially means "you and your husband shouldn't have children?"

Dylan16807 13y ago
They'd probably feel a hundred times worse if they found out by observing the symptoms in those future children.
unclebucknasty 13y ago
I think one can make a million hypothetical arguments against the testing. But, I just don't see people taking the test at face value and making major life decisions without further follow-up. I think most reasonable people would consider it a screen. If the testing was wildly inaccurate, then that's another issue. It almost becomes more an FTC consumer protection-type matter at that point. But, there is no indication that this is the problem. They go on to state that their testing is done in CLIA-certified laboratories: https://www.23andme.com/howitworks/ https://www.23andme.com/howitworks/ (near bottom of page) http://www.cms.gov/Regulations-and-Guidance/Legislation/CLIA/index.html?redirect=/clia/ http://www.cms.gov/Regulations-and-Guidance/Legislation/CLIA... BTW, I'm not really defending the service, per se. In fact, I have issues with it that are more along the privacy lines. I just don't see where there's any proof that it has an outsized chance of ruining lives any more than, say, in-home HIV testing.