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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Biodesix Expands Bio-Rad Partnership for Droplet Digital PCR Assay Development
The agreement focuses on clinical validation of ESR1 mutation detection assay for advanced breast cancer testing using ddPCR technology.
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Molecular Platform Shows Promise for Detecting Asymptomatic Malaria Cases
A field-deployable test demonstrates high sensitivity in identifying low-level infections that traditional methods miss, potentially supporting elimination efforts.
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OncoHost Receives New York State Laboratory Permit for Precision Oncology Test
The permit enables the company to offer its PROphetNSCLC test to physicians and patients across New York State, completing nationwide availability.
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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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