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Posts Currently viewing the tag: "LDT Regulation"

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 number of tests are offered without documentation of clinical validation. For example, only half of…(Read More)

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 tests. In this context I thought it would be interesting, as a…(Read More)

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 Regulation Can’t Keep Pace With Innovation Dara Aisner, M.D., Ph…(Read More)

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 questions covering everything from the definition of a diagnostic device, to risk definitions, to what…(Read More)

There have been some interesting developments over the last few weeks in the ongoing discussion about FDA’s desire to regulate LDTs. Pathologists Still Oppose Regulation At the annual meeting Nov. 12-14 of the Association for Molecular Pathology (AMP) a special late-breaking “Conversations with the FDA” session was held to discuss FDA’s…(Read More)

I finally had a chance to watch the complete Congressional hearing on LDT regulation that took place several weeks ago. Several interesting things came up which I haven’t seen mentioned anywhere else: – The issue of FDA’s authority to regulate LDTs may not in fact be settled. Congressman Michael Burgess (R, Texas) stated that…(Read More)

The FDA today released the full version of its draft guidance on LDT regulation, and also its draft guidance covering notification and reporting by LDT developers (the previously released copy of the regulatory guidance was titled “Anticipated Details,” and was pre-released in response to Congressional pressure). The regulatory guidance seems essentially unchanged from the…(Read More)