Is FDA Approval of MammaPrint a Big Step in Breast Cancer Treatment?
The MammaPrint test is a gene test that works by comparing seventy genes and generating a number on a scale of one to one hundred the chances of a breast cancer relapse. It is most beneficial in deciding who isn't at risk for a relapse than it is at deciding who is. For the women that are deemed to be low risk, this means that foregoing chemo therapy is a realistic option in their health care. However, Oncotype DX has been used for just that in the last three years. For the women deemed at high risk, a more aggressive treatment can be pursued, although being deemed at high risk is not equitable to being high risk. The treatment with chemo therapy has more severe side effects than one without, but has a higher chance of destroying the breast cancer with minimal relapses.
Until now, this type of test was not formally approved by the FDA because it falls within the "doctor ordered services" boundaries. However, there is currently a discussion underway about whether testing needs to be done in this area, especially since one company has stepped forward and started the ball rolling. What does all this mean to women in the U.S.?
Not too much, at least for a while. As it is, the MammaPrint test might be FDA approved, but there is no set U.S. price for the test yet. Also, it would take several months for the FDA to make formal testing mandatory for the gene tests. Once cancer specialists can choose MammaPrint over others like Oncotype DX, the choice will probably be made by insurance companies and the patient's ability to pay.
The most important thing to keep in mind though is that the FDA approval is no indication that the test lengthens survival rates due to physicians having the information gained from the test. The FDA approval of the test should not be taken as an indicator that the test is some major step forward in the fight against breast cancer. It is simply more red tape that has been filed.
Published by Sam Smith
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Cheerios is Considered an Unapproved Drug by the FDAI find this fascinating because for one I am really sick and tired of all the bogus claims companies make from take off 20 years to cure cancer. 
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- FDA approval does not mean that it is a new type of test.
- FDA approval of MammaPrint did start a discussion of whether gene tests need to be approved.