Geneseeq Technology secured 510(k) clearance from the US FDA for its GeneseeqPrime next-generation sequencing (NGS) tumor profiling assay targeting solid malignancies. The test covers 425 cancer-related genes, detecting diverse genomic alterations including SNVs, indels, amplifications, and translocations, alongside tumor mutational burden and microsatellite instability reporting. Integrated with Geneseeq's proprietary bioinformatics platform, the test aims to expand access to precision oncology diagnostics domestically. The FDA clearance follows CE marking and Chinese regulatory approvals, reinforcing Geneseeq’s positioning in the global oncology diagnostic market.