Posted on 11/12/2025
With FDA., CE-IVD, and NMPA approvals, the comprehensive tumor profiling kit enables decentralized, standardized oncology testing worldwide
Toronto, Canada – September 2, 2025 – Geneseeq Technology Inc. today announced that the U.S. Food and Drug Administration (FDA) has granted 510(k) clearance for GENESEEQPRIME® NGS Tumor Profiling Assay, an in vitrodiagnostic (IVD) test kit that uses next-generation sequencing (NGS) of DNA from FFPE tumor tissue to detect tumor gene alterations across a comprehensive mult...