In February of last year the FDA hosted a two-day workshop focused on technical and regulatory considerations related to the use of next generation sequencing (NGS) diagnostics in clinical practice. This was a very forward-thinking move on the part of FDA, as...
We have written extensively about health system regulation in this blog, with a keen interest in how LDT regulation will shake out. In our other blog we’ve even argued strongly for caution in LDT regulation, primarily to avoid stifling innovation. However, our...
In this blog we have regularly assumed (without hard data until now) that most biomarker innovation was taking place in laboratory-developed tests (LDTs) as opposed to tests cleared and approved by FDA, and we can now confirm that this assumption is correct. Now that...
In mid-2015 we worked hard to add a new source of evidence for biomarkers: Laboratory Developed Tests, or LDTs. This was a huge milestone for Amplion. We successfully used our technology to identify biomarkers in a new information source very quickly without...
At Amplion we have a commercial interest in access to high quality clinical information that can inform and contribute to our flagship product, BiomarkerBase. However, we are truly passionate about contributing to higher quality, more personalized, medical...
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