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.
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.
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.
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.
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.
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.
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:
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.
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.