The TGA assess risk versus benefit. In the case of Colostat this relates strongly to the test's ability to avoid false positives, which are by nature cause distress to patients. Based on this, I imagine that statisticians will be involved in the TGA assessment process, perhaps academics who specialise in population screening strategy.
From our collective research, I think that most here are confident that Colostat's main advantage is that it has very low false positives, with benefits outweighing definitely outweigh this likelihood.
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