Mihaescu, R., van Hoek, M., Sijbrands, E., Uitterlinden, A., Witteman, J., Hofman, A., van Duijn, C., & Janssens, A. (2009). Evaluation of risk prediction updates from commercial genome-wide scans Genetics in Medicine, 11 (8), 588-594 DOI: 10.1097/GIM.0b013e3181b13a4f
However, far from supporting calls to forbid such tests being available DTC, this highlights the need for transparency in the provision of information.Companies offering genome-wide risk prediction services should ensure that their customers understand that, whilst the measurement of the DNA sequenceitself (the assay) will remain constant, the interpretation of the result (the test) is likely to change as the science develops.
We need to decide here. Are these tools for medicine or not?
Today I say they are not great tools. Maybe in 30 years when we have further data. My point is that we should not be hinting or inferring that they do (Currently) have great predictive power in risk prediction. That is one of the problems.
The second problem is that these Non-clinical tools put the consumer/patient at risk of disclosure of information which could be (IN the future) very predictive.
The third problem is that these companies make current genetic testing tools seem less valid (In the eyes of many pragmatic doctors) This leads to an increased skepticism of what is a good clinical tool, BRCA/HNPCC etc.....
Regulation is one way to say "This is a good Tool, this is not"
A physician's mind works just the same when it comes to regulation......they say "This is a good tool, this is not" merely based on the regulation of these tools, which, let's face it, there is little if any being had here or even being created.....
Gatekeepers only work, if the gatekeeper knows enough about the field to make informed choices.
We all saw a terrible case of this going awry with Michael Jackson's Propofol induced death.......
So this is not to place physicians as the end all be all, but until these companies are willing to state that their tests have limited ability NOW, then I am unwilling to give them a pass.......
Sure, let them play up what "Might be" But, playing up what currently isn't is dishonest.
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McCulloch accuses Steig et al. of appropriating his âfindingâ that Steig et al. did not account for autocorrelation when calculating the significance of trends. While the published version of the paper didnât include such a correction, it is obvious that the authors were aware of the need to do so, since in the text of the paper it is stated that this correction was made. The corrected calculations were done using well-known methods, the details of which are available in myriad statistics textbooks and journal articles. There can therefore be no claim on Dr. McCullochâs part of any originality either for the idea of making such a correction, nor for the methods for doing so, all of which were discussed in the original paper. Had Dr. McCulloch been the first person to make Steig et al. aware of the error in the paper, or had he written directly to Nature at any time prior to the submission of the Corrigendum, it would have been appropriate to acknowledge him and the authors would have been happy to do so. Lest there be any confusion about this, we note that, as discussed in the Corrigendum, the error has no impact on the main conclusions in the paper.