New Approaches To Identifying Targeted Therapeutics

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...

Announcing the BiomarkerBase and SolveBio partnership

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...

Light Hand Regulating Laboratory Developed Tests (LDTs)

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...

Regulatory Delays Are Keeping the Diagnostics Industry in Limbo

An FDA official recently stated that the final version of the draft guidance regarding regulation of laboratory-developed tests (LDTs) is not likely to be released before the end of this year.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...