Diagnostic Precision

A SeraCare blog focused on precision medicine and advanced clinical diagnostics

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Trevor Brown

Recent Posts

LDT Oversight: Why the FDA makes a point

Category: FDA, LDT, reference materials

Posted by Trevor Brown on Dec 21, 2015 12:00:00 AM
Recently, the FDA upped the ante in the ongoing debate over its desire to regulate laboratory developed tests (LDTs) with the release of a report detailing the ‘real and potential harms to patients and to public health’ arising from LDTs. This debate has been heating up for several years now—not coincidentally with the emergence of precision medicine and the rapid adoption of data-intensive tools such as Next Generation Sequencing (NGS) and the growing pipelines of targeted therapeutics. One might argue that the horse has already left the barn and the FDA are trying to corral it back in.
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