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Evaluating the Clinical Performance of In Vitro Diagnostic Tests: A Comprehensive Guide

In the rapidly evolving realm of contemporary healthcare, in vitro diagnostic (IVD) tests have emerged as indispensable tools for detecting, managing, and preventing diseases. Spanning from straightforward blood glucose tests to intricate genetic analyses...

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The New Landscape of Laboratory-Developed Tests: A Regulatory Overview for Anatomic Pathology

Laboratory-developed tests (LDTs) have long been a critical component of personalized medical care, particularly in the field of anatomic pathology. Historically, LDTs were developed and used by clinical laboratories without specific regulatory oversight...

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