The NGS-based test joins CE-IVD and NMPA approvals for global market access.
The US Food and Drug Administration (FDA) has granted 510(k) clearance to Geneseeq Technology Inc’s GENESEEQPRIME NGS Tumor Profiling Assay, an in vitro diagnostic test that uses next-generation sequencing to detect tumor gene alterations in patients with solid malignant neoplasms.
The assay analyzes 425 cancer-related genes from FFPE tumor tissue, detecting single-nucleotide variants, insertions/deletions, and selected gene amplification and translocations. The test also reports microsatellite instability and tumor mutation burden. Analytical and clinical validation studies conducted across multiple US clinical laboratories demonstrated high sensitivity, specificity, and reproducibility across variant types.
The ready-to-use in vitro diagnostic kit enables decentralized implementation in oncology laboratories while maintaining globally harmonized standards. The assay pairs with GENESIS by GENESEEQ, the company’s proprietary bioinformatics pipeline and reporting system validated across multiple CLIA/CAP-accredited laboratories.
“FDA 510(k) clearance of GENESEEQPRIME marks a major milestone for Geneseeq and for the broader oncology community,” says Xue Wu, PhD, CEO of Geneseeq Technology Inc, in a release. “By enabling laboratories to deliver high-quality genomic profiling locally on a standardized, regulatory-cleared platform, we are expanding patient access to precision medicine and supporting innovation in cancer care worldwide.”
Global Regulatory Strategy
The FDA clearance follows previous regulatory approvals including CE-IVD marking in Europe and NMPA approval in China. This multi-regional approach strengthens Geneseeq’s ability to support clinical trials, biomarker-driven drug development, and future companion diagnostic strategies by offering a standardized platform that promotes data harmonization across geographies.
Toronto- and China-based Geneseeq operates CAP- and CLIA-certified laboratories and maintains a portfolio spanning tumor profiling, cancer-specific diagnostic panels, minimal residual disease monitoring, and multi-cancer early detection solutions. Four other Geneseeq panels have received CE-IVD marking, and the company’s multi-cancer early detection assay CanScan has been granted FDA Breakthrough Device Designation.
The company partners with hospitals, academic institutions, and pharmaceutical companies to advance precision medicine and accelerate biomarker-driven therapeutic development.
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