Clinical Lab Management
News on issues related to managing clinical laboratories.
LabGenomics USA Acquires Integrated Molecular Diagnostics
The deal brings the total number of CLIA-certified labs that LabGenomics has in the US to four. Last year, the firm entered the US market with the buy of QDx Pathology.
Quest Diagnostics Wins CDC Contracts for Avian Flu, Oropouche Testing
Quest has developed a multi-target molecular test for avian influenza A H5 virus that it plans to make available by the end of October.
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.
FDA Issues Draft Guidance on Process for Modifying Medical Devices Including Lab Tests
The guidance covers predetermined change control plans, which some in the lab industry are looking to for flexibility following FDA's recent rule on lab-developed 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.