Geneseeq Technology has received FDA 510(k) clearance for its GeneseeqPrime next-generation sequencing (NGS) tumor profiling assay. This in vitro diagnostic test detects multiple classes of genomic alterations in tumor tissue samples, covering 425 cancer-related genes. The assay aids precision medicine through comprehensive genomic profiling and includes proprietary bioinformatics for analysis and reporting. The clearance expands clinical access to standardized genomic testing in oncology.
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