[midjji]

For a test manufacturer you are right, and they aren't responsible for accounting for general population frequencies, or conditional frequencies based on things like some sibling has it etc. But there is no need to regulate that. But the serivice in question isnt a test manufacturer, its diagnostics, and they are responsible for this. I think a company selling a diagnostics service should be required to prominently display reasonably accurate FP,TP,FN,TN rates for gen pop, as the next example will show.

This is is not a legal problem, its a customer experience one, and as such its very much what the free market does well. A clever company could say that the tests service we provide works in a two stage process where a preliminary test is used to identify which conditions need to be investigated further, the results of which are presented in a meeting with one of our doctors were the results are explained and additional tests are performed to resolve any ambiguity. This combines the benefits of sensitivity, and specificity in a resource efficient way, and does not provide the user with any scary results before a certain answer is available. The FP,FN,TP,TN probabilities for gen pop for such a company would be much better than those of companies trying to do so in a single pass. But for these figures to mean anything regulating that they are available and reasonably accurate is key to ensure an efficient market.

Another problem is of course that the tests themselves are shit, or the rates based on poor data. The requirement on reasonably accurately reported gen pop rates help with this however, and I see no way around legally forcing diagnostic services providers to prove this. And until someone does, my patent pending algorithm(){return false} tests for all rare genetic disorders with excellent accuracy^^