You are right about your understanding on the risk distribution, i.e. relatively small proportion of women have highly elevated risk. But at the same time the differences in risks used to define action points for different or additional screening measures are not that drastic either, for example to consider annual MR if lifetime risk is between 15-20% and to recommend it if >20%, which are increases of 1.25 to 1.66 fold respectfully over the background 12 % lifetime risk. So as you con see on our web pages and in the sample report that I am attaching that a significant proportion of women have a risk results that can significantly elevate their risk over their background population risk to a action points already defined by for example the American cancer society and the NCCN. This is all that matters because we are not suggesting anything any new criteria for breast cancer screening but that the results of the deCODE BreastCancer test be superimposed on the current recommendations and that the risk results can be used to multiply the individual risk defined by for example the Gail model. The fact is that for the common women, especially with moderate family history there have not been available any tests but only clinical recommendations that I believe are no more statistically robust than the results of our test. Physicians have been left with little tools to make decisions on actions or no actions when recommending women on their breast screening. But this is what medicine is all about, physicians in the end making judgement calls using all the information available to them, and the deCODE BrestCancer test results are statistically solid and can have a significant impact on women’s’ risk for a significant proportion of women. Regarding risk results below 1.0 we believe certainly that they should be taken in account as well, for example when evaluating a women at a lifetime risk of 15-20% by risk modelling and considering and discussing with here if an MRI should be added or not. More of these is addressed in our sample report that I have attached.

Regarding the OncoVue test we have always felt somewhat uncomfortable because of their lack of publishing on their complete analytical method as used in the test and physicians we have talked with say they always refer to proprietary data and are secretive in terms of their calculations. On the other hand all of our markers are published as we find them in great journals to make it easy for others to replicate and understand our tests. If you have a reference that you can point me to on OncoVue’s methods I would most appreciate it.

All the relevant references for our test and the markers are cited on our web pages but our representatives will be most happy to send you paper copies if you like.

Sincerely,

Kristleifur Kristjansson
VP of Medical Affairs
deCODE genetics

Thank you.