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Posts From the monthly archives: "July 2015"

Making the maximum use of discoveries that have already been made is a central interest of mine, and a couple of recent articles have described novel ways that targeted therapies might be “discovered” for individual patients. A group at MIT has developed a device about the size of a grain of rice which can deliver…(Read More)

At Amplion we are passionate about bringing our clinically validated biomarker information to the places you already work. As we embed our information into your existing workflow our time-to-add-value is even shorter – as always you should checkout our application at biomarkerbase.com. We work hard to ensure our features and partnerships enable…(Read More)

Hello and welcome to the second half of the first Amplion company blog where I mapped out why our team is dedicated to seeing the promise of personalized medicine fully realized. So now I’m going to cover why we believe that 510(k)-style regulation of LDTs should not be pursued. 510(k) is…(Read More)

An FDA official recently stated that the final version of the draft guidance regarding regulation of laboratory-developed tests (LDTs) is not likely to be released before the end of this year. Elizabeth Mansfield, director of personalized medicine at the FDA’s Center for Devices and Radiological Health, was a panelist at the Clinical Laboratory…(Read More)