Comprehensive Tumor Profiling Kit Decentralizes and Standardizes Oncology Testing

Traditional approaches often struggle to capture the full range of genetic alterations that drive disease, limiting precision medicine strategies. Now, a comprehensive genomic profiling panel for the early and reliable detection of clinically relevant tumor gene changes reveals clinically actionable information for therapy selection.

Geneseeq Technology’s (Toronto, Canada) GeneseeqPrime NGS Tumor Profiling Assay provides information on clinically actionable genomic alterations and their associated targeted therapy. This next-generation sequencing (NGS) test analyzes DNA from FFPE tumor tissue to detect alterations across 425 cancer-related genes, including SNVs, indels, amplifications, translocations, MSI, and TMB. Delivered as a ready-to-use kit, it enables decentralized adoption with standardized workflows across oncology laboratories.

Analytical and clinical validation studies across multiple U.S. clinical laboratories demonstrated high sensitivity, specificity, and reproducibility for the GeneseeqPrime assay. The assay is paired with GENESIS by Geneseeq, a proprietary bioinformatics pipeline and reporting system validated in CLIA/CAP-accredited labs. Together, these components provide a consistent data analysis and reporting framework, supporting its intended clinical use in oncology.

The U.S. Food and Drug Administration (FDA) has granted 510(k) clearance for GENESEEQPRIME NGS Tumor Profiling Assay, strengthening its role in biomarker-driven drug development, multi-regional clinical trials, and future companion diagnostics. The assay supports globally harmonized standards, adding to CE-IVD marking in Europe and NMPA approval in China. This milestone positions Geneseeq to expand patient access to precision oncology, with additional applications in standardized testing and future CDx strategies worldwide.

“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. “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.”

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