GeneseeqPrime® Gains FDA 510(k) Clearance

With FDA., CE-IVD, and NMPA approvals, the comprehensive tumor profiling kit enables decentralized, standardized oncology testing worldwide

TORONTO, Sept. 2, 2025 /CNW/ - 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 vitro diagnostic (IVD) test kit that uses next-generation sequencing (NGS) of DNA from FFPE tumor tissue to detect tumor gene alterations across a comprehensive multi gene panel in patients with solid malignant neoplasms.

The GENESEEQPRIME^® assay interrogates 425 cancer-related genes, detecting multiple classes of genomic alterations - including single nucleotide variants (SNVs), insertions/deletions (indels), and selected gene amplification and translocations - while also reporting microsatellite instability (MSI) and tumor mutation burden (TMB). Analytical and clinical validation studies conducted across multiple U.S. clinical laboratories demonstrated high sensitivity, specificity, and reproducibility across variant types, supporting the assay's intended use in clinical oncology.

Delivered as a ready-to-use IVD kit, GENESEEQPRIME^® enables decentralized implementation in oncology laboratories, supporting local adoption while ensuring globally harmonized standards. The assay is paired with GENESIS by GENESEEQ^®, the company's proprietary bioinformatics pipeline and reporting system validated across multiple CLIA/CAP-accredited laboratories. The whole assay solution provides laboratories with a streamlined workflow and a consistent data analysis and reporting framework.

FDA clearance strengthens Geneseeq's ability to support multi-regional clinical trials, biomarker-driven drug development, and future companion diagnostic (CDx) strategies by offering a standardized, validated platform that promotes data harmonization and operational efficiency across geographies. This milestone follows prior regulatory achievements, including CE-IVD marking in Europe and NMPA approval in China, further positioning Geneseeq as a global leader in precision oncology. 

"FDA 510(k) clearance of GENESEEQPRIME^® marks a major milestone for Geneseeq and for the broader oncology community," said Xue Wu, PhD, CEO of Geneseeq Technology Inc. "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."

About Geneseeq

Geneseeq Technology Inc. is a research-driven global leader in precision oncology, pioneering next-generation sequencing (NGS) technologies to transform cancer detection, diagnosis, and treatment. Its portfolio spans comprehensive genomic profiling across tumor types, cancer-specific diagnostic panels, minimal residual disease (MRD) monitoring, and multi-cancer early detection (MCED) solutions.

The company's flagship GeneseeqPrime^® tumor profiling assay is now FDA-cleared, CE-IVD marked, and NMPA-approved, ensuring accessibility across major jurisdictions. In addition, four other Geneseeq panels have received CE-IVD marking, and its MCED assay CanScan^® has been granted FDA Breakthrough Device Designation.

Headquartered in Canada and China, Geneseeq operates CAP- and CLIA-certified laboratories and partners with hospitals, academic institutions, and pharmaceutical companies worldwide to advance precision medicine and accelerate biomarker-driven therapeutic development.

SOURCE Geneseeq Technology Inc.

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