The regulatory landscape of precision oncology laboratory medicine in the United States: Perspective on the past five years and considerations for future regulation

What is the current status of laboratory developed tests (LDTs) and the U.S. Food and Drug Administration’s (FDA) approach to them? What are the arguments for and against their regulation? In this 2020 review article published in Practical Laboratory Medicine, University of Washington’s Eric Konnick covers the current U.S. regulatory environment for LDTs, as well as recent developments since the October 2014 FDA release of LDT draft guidance. Konnick then provides extensive commentary on the scope of LDT regulation in the U.S., including perceived risks to patients, LDT accuracy and equivalency, and how regulatory certainty fits into LDT innovation. He closes with recommendations for approaching future LDT regulation, concluding that “identifying tools that can be leveraged to improve laboratory test quality may offer many benefits that do not necessarily require a burdensome regulatory framework.”

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