BLOGS

LDTs

Zika Virus Testing and the Continuing Saga of FDA Oversight of Lab-Developed Tests

Published by Irving Nachamkin, DrPH, MPH, D(ABMM), FAAM, FIDSA, on May 09, 2016

The Zika outbreak provides a good example of why the FDA’s position on LDTs is misguided.

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Laboratory Developed Tests (LDTs)

Published by Irving Nachamkin, DrPH, MPH, D(ABMM), FAAM, FIDSA, on December 22, 2015

We need congressional action to modernize CLIA regulations that ensure the quality of Lab Developed Tests (LDTs), rather than having the FDA impose new and unrealistic regulations on top of CLIA requirements.

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