A study described in a recent paper in the Journal of the National Cancer Institute analyzed the marketing of laboratory-developed tests (LDTs) for cancer by 55 different companies, academic institutions and other organizations. The analysis concludes that a large...
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...
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...
JAMA published two Online First opinion pieces on January 5, covering each side of the proposed FDA regulation of LDTs. Pro-Regulation Opinion The opinion in favor of FDA regulation was written by Joshua Sharfstein, MD, from the Department of Health and Hygiene. Dr....
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...
