On the eve of the FDA's public hearing on their draft guidance on in vitro diagnostic multivariate index assays (IVDMIAs) a group comprised of molecular diagnostic companies and investors known as The Coalition for 21st Century Medicine has asked the FDA to follow a more formal process in determining the future of this promising technology. What is being considered here is whether IVDMIAs may be subject to FDA regulation and if so, which ones and how much. Added regulation means added resources, resources that could be spent on further research and development and expansion of technologies that are still very much in a nascent stage. These are the early days of personalized medicine, a time in the life cycle of a technology where a significant investment is required to make headway. The added burden of regulation may present a set back to the industry just when businesses were beginning to show some returns.
Although regulation of IVDMIAs is inevitable, requiring the FDA to go through a more formal process before initiating regulation will buy some time, time to bring more products into the market, gain more credibility with the insurance companies and bring a greater return to investors before the added costs of regulation come into play.
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Breast Cancer pink prognosis
Common Breast Cancer Myths
The first myth pertaining to this disease is that it only affects women.
Second myth that is associated with this disease is that if one has found a lump during an examination, it is cancer.
Third is that it is solely hereditary
The next myth associated with breast cancer is downright ridiculous. Would you believe, that in this day and age, some individuals still think that breast cancer is contagious?
Conversely, some individuals foolishly believe that breast size determines whether or not one gets cancer.
Finally, another myth that is associated with this disease is that it only affects older people. This is not so. Although the chance of getting breast cancer increases with age, women as young as 18 have been diagnosed with the disease.
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Breast Cancer prognosis
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