27 ms·

Without an appropriate study to determine reasonable efficacy, it is possible that the diagnostic technique could result in a large number of false positives.

Without an appropriate study to determine reasonable efficacy, it is possible that the diagnostic technique could result in a large number of false positives. This could result in a large number of unnecessary follow-up BRCA tests which could potentially increase the waiting time for test results or unduly raise costs for lots of patients. Not to mention the stress of feeling like you may be suffering from a potentially expensive and life-threatening illness. So: totally reasonable.

judk 13y ago
Why more than 1 follow up test?
- gorner 13y ago
  Multiple unneeded follow-up tests across the population, not per person.
  - grandalf 13y ago
    There is always a point in any discussion of medicine where broad "public health" concerns creep in. If we really cared about public health we'd have a drastically different system. In any case I think it's hard to make a persuasive argument that if the members of the public were only kept more naive about their own health risks, public health would improve.
grandalf 13y ago
Your verdict of reasonableness depends on the idea that physicians are not going to be able to properly advise patients who they think might have gotten a false positive result. Considering that over half of American adults believe Elvis is alive, I think the small percentage who may slightly overreact to the kind of presentation that 23andme gives of these kinds of results is a complete non-issue.
- tptacek 13y ago
  You seem to believe the average doctor is well-versed in the mechanics of genetic testing, or (perhaps equivalently) that the average doctor isn't wholly dependent on the mechanisms of FDA approval for product selection.
  - grandalf 13y ago
    Any doctor educated in the past two decades is well versed in genetic testing, and any doctor specializing in areas where genetic testing is a frequently used aspect of planning/diagnosis (such as OB/GYN) will be highly familiar even if trained long ago. The 23andme product explains explicitly how it should be used by a physician, and there are all kinds of warnings and checkboxes before the user is shown any data that falls into the area of overlap.
    - tptacek 13y ago
      Perhaps any one of several trained medical professionals on HN could chime in here to explain (a) how suitable 23AM's current product is for clinical use and (b) how competent a typical physician is at evaluating clinical genomics products without FDA's assistance. 'carbocation? 'niels_olson? ('carbocation has already expressed some tacit support for FDA's action, but I'm not qualified to interpret it in the context of this particular subthread).
    - dragonwriter 13y ago
      > The 23andme product explains explicitly how it should be used by a physician Generally, for diagnostic tools, drugs, etc., it is not enough that the product labelling explains how it should be used, but it is required to demonstrate to the FDA that there is evidence that it works as marketed when used according to those directions. The FDA Warning Letter specifically calls out 23andMe's failure to either identify existing approved products on the market to which the product is equivalent (which wouldn't reduce the requirements for proving this) or to meet the requirements for demonstrating the effectiveness of their offering as a new product without existing, approved equivalents.

judk 13y ago

Why more than 1 follow up test?

gorner 13y ago
Multiple unneeded follow-up tests across the population, not per person.
- grandalf 13y ago
  There is always a point in any discussion of medicine where broad "public health" concerns creep in. If we really cared about public health we'd have a drastically different system. In any case I think it's hard to make a persuasive argument that if the members of the public were only kept more naive about their own health risks, public health would improve.

grandalf 13y ago

Your verdict of reasonableness depends on the idea that physicians are not going to be able to properly advise patients who they think might have gotten a false positive result. Considering that over half of American adults believe Elvis is alive, I think the small percentage who may slightly overreact to the kind of presentation that 23andme gives of these kinds of results is a complete non-issue.

tptacek 13y ago
You seem to believe the average doctor is well-versed in the mechanics of genetic testing, or (perhaps equivalently) that the average doctor isn't wholly dependent on the mechanisms of FDA approval for product selection.
- grandalf 13y ago
  Any doctor educated in the past two decades is well versed in genetic testing, and any doctor specializing in areas where genetic testing is a frequently used aspect of planning/diagnosis (such as OB/GYN) will be highly familiar even if trained long ago. The 23andme product explains explicitly how it should be used by a physician, and there are all kinds of warnings and checkboxes before the user is shown any data that falls into the area of overlap.
  - tptacek 13y ago
    Perhaps any one of several trained medical professionals on HN could chime in here to explain (a) how suitable 23AM's current product is for clinical use and (b) how competent a typical physician is at evaluating clinical genomics products without FDA's assistance. 'carbocation? 'niels_olson? ('carbocation has already expressed some tacit support for FDA's action, but I'm not qualified to interpret it in the context of this particular subthread).
  - dragonwriter 13y ago
    > The 23andme product explains explicitly how it should be used by a physician Generally, for diagnostic tools, drugs, etc., it is not enough that the product labelling explains how it should be used, but it is required to demonstrate to the FDA that there is evidence that it works as marketed when used according to those directions. The FDA Warning Letter specifically calls out 23andMe's failure to either identify existing approved products on the market to which the product is equivalent (which wouldn't reduce the requirements for proving this) or to meet the requirements for demonstrating the effectiveness of their offering as a new product without existing, approved equivalents.