FDA-Approved Biomarker Panels: The Good, The Bad, and The Ugly

Here at Amplion we are currently thinking very hard about how to represent in BiomarkerBase the ways in which emerging biomarkers are naturally grouping into panels, based on how they are used in clinical trials, described in the literature, and appear in clinical...

LDT Workshop Reveals New Insights

For those who were willing to listen through a lot of repetitive presentations during last week’s FDA workshop covering the Agency’s proposed regulation of LDTs, some interesting points were made by at least a few of the presenters and panelists. FDA...

House Committee Seeks Feedback on LDT Regulation

The House Energy and Commerce Committee is soliciting feedback from “all interested stakeholders” on just about every central issue related to FDA’s proposal to regulate LDTs. The Committee posted a white paper on December 9 that lists eleven broad...