FDA’s LDT proposal means ‘whole new ballgame’ for labs

The Food and Drug Administration’s plan to subject many laboratory-developed tests to a new layer of regulatory requirements over the course of the next decade is drawing sharply contrasting reactions from stakeholders who view it as either an essential step to improve patient safety or a hindrance that will stifle diagnostic innovation and test improvement.

Despite that fundamental disagreement on the policy’s substance, there does seem to be consensus among informed observers that the FDA is determined to take action, that legislative intervention to block the agency faces long odds, and that the agency’s final guidance will create a regulatory challenge for labs unrivaled by anything out of Washington since CLIA ’88.

My feature article in the October edition of CAP TODAY. Read the whole shebang.