Clinical Lab Management
News on issues related to managing clinical laboratories.
FDA IVD Reclassification Plan May Reduce Regulatory Burden for Test Developers, But Questions Remain
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The plan, announced in January, would reclassify many Class III in vitro diagnostic devices as Class II, impacting companion diagnostic and infectious disease tests.
AMP Sues FDA Over Laboratory-Developed Test Final Rule
Filed in the US District Court for the Southern District of Texas, the lawsuit is the second legal challenge to the rule following a suit filed by ACLA in June.
The rule could force labs to shed tests deemed nonessential to their institutions' missions as well as influence decisions around instrumentation and vendor choices.
Labcorp Receives FDA De Novo Authorization for Blood-Based Tumor Mutation Profiling Assay
The company's PGDx Elio plasma focus test is a next-generation sequencing assay that allows for mutation profiling of solid tumors from blood samples.
Becton Dickinson, Quest Diagnostics Collaborate on CDx Development
The firms will develop, manufacture, and commercialize flow cytometry-based companion diagnostics for cancer and other diseases.