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GENESEEQPRIME® NGS Tumor Profiling Assay, an in vitrodiagnostic (IVD) test kit
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Geneseeq Technology Inc. has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for its GENESEEQPRIME® NGS Tumor Profiling Assay. This achievement marks a significant milestone for the company and the broader oncology community, as it allows for the decentralized implementation of a ready-to-use in vitro diagnostic (IVD) test kit in clinical laboratories.

The assay is designed to analyze DNA from tumor tissue using next-generation sequencing (NGS) to detect a wide range of genomic alterations across 425 cancer-related genes. It identifies single nucleotide variants (SNVs), insertions/deletions (indels), gene amplification, and translocations, while also reporting on microsatellite instability (MSI) and tumor mutation burden (TMB).

The FDA clearance was granted after extensive analytical and clinical validation studies conducted in multiple U.S. clinical laboratories demonstrated high sensitivity, specificity, and reproducibility. The GENESEEQPRIME® assay is paired with the company's proprietary bioinformatics pipeline, GENESIS by GENESEEQ®, providing laboratories with a streamlined workflow and consistent data analysis. This standardization not only supports local adoption of precision medicine but also facilitates global data harmonization and operational efficiency, which is crucial for multi-regional clinical trials, biomarker-driven drug development, and future companion diagnostic (CDx) strategies.

This regulatory success in the U.S. builds on Geneseeq's prior achievements, including CE-IVD marking in Europe and NMPA approval in China, solidifying its position as a global leader in precision oncology. By enabling laboratories to deliver high-quality genomic profiling on a standardized, regulatory-cleared platform, the company aims to expand patient access to precision medicine worldwide. As a research-driven company headquartered in Canada and China, Geneseeq operates CAP- and CLIA-certified laboratories and collaborates with hospitals, academic institutions, and pharmaceutical companies globally to advance cancer care. The company’s portfolio includes various other solutions, such as minimal residual disease (MRD) monitoring and multi-cancer early detection (MCED) assays, with one such assay already granted FDA Breakthrough Device Designation.

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