Waiting for Guidance

Monday, June 11, 2012

The controversy around LDTs seems to have gone mostly quiet lately, but that's not because it's resolved or that there is no more to be said. FiercePharma's new e-ebook on the topic is both a good piece of reporting on the controversy and an excellent reminder why the discussion is is important to continue. Waiting for Guidelines: Will FDA Take The Reins of Laboratory-Developed Tests? raises an important question; it's one I'd love to see answered before I retire.

I disagree that FDA's request for an appropriate study for a PMA costitutes Sequenom being "thwarted" (as reported in the Sequenom Saga section). I'm certain, however, this is likely how the Sequenom PR office described it. Seems to me FDA's job is to ask us to prove these tests actually work as advertised. But there's always more than one side to the story.

The larger, more important questions are: what has changed and why might it be more important now than in the distant past to regulate many LDTs? How do we address the challenge of bad actors entering a marketplace with little regulation? These are issues that many of the well-validated LDTs are beginning to ask and I'm happy to see this ebook raise them as well.


Tags: LDTs, PMA, Policy, Politics

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