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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FDA Clears Enhanced Microbial Identification System Features
New clearances expand MALDI-TOF platform capabilities with improved software, faster sample prep, and broader species coverage.
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HistoIndex to Debut FibroSIGHT Plus for Liver Fibrosis Assessment at AASLD The Liver Meeting
The CLIA-lab test marks HistoIndex’s expansion from research to routine diagnostics, offering AI-based digital pathology for quantitative liver fibrosis assessment in patients with MASH.
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