AMP Awards Pathologist for Role in Laboratory-Developed Test Litigation
The pathologist served as joint plaintiff in successful lawsuit challenging FDA regulation of LDTs as medical devices.
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Search Results for: compliance
Breaking Down Barriers to Cervical Cancer Screening Compliance by Introducing Self-Collection
Self-collection for HPV and other infections offers a more convenient, private way to complete recommended screenings—helping reach women who might otherwise delay or skip care.
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FDA Grants Breakthrough Device Designation for Whole Genome and Exome Tests
The designation accelerates regulatory review for GeneDx’s ExomeDx and GenomeDx testing platforms designed to diagnose rare diseases.
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ctDNA Blood Test for Cancer Monitoring Launches in Europe
German laboratory brings tumor-informed MRD testing to European market through licensing agreement with Quest Diagnostics subsidiary.
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FDA OKs QuidelOrtho’s Gel-Based Direct Antiglobulin Testing Card
The card pairs with the Ortho Vision Platform to provide a complete gel-based DAT solution for transfusion medicine laboratories.
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