GeneseeqPrime® Receives FDA Clearance for Advanced Tumor Profiling Technology

GeneseeqPrime® Achieves FDA 510(k) Clearance

Geneseeq Technology Inc. is making headlines with the announcement of the FDA's recent authorization of its GENESEEQPRIME® NGS Tumor Profiling Assay. This significant development represents a pivotal advancement in the realm of oncology diagnostics, allowing for a more sophisticated analysis of tumor genetics.

On September 2, 2025, the FDA granted 510(k) clearance for this in vitro diagnostic (IVD) test kit, which utilizes next-generation sequencing (NGS) technology to analyze DNA extracted from FFPE (formalin-fixed, paraffin-embedded) tumor tissue. The assay is designed to detect various genetic alterations associated with solid malignant cancers, covering a robust panel of 425 genes.

The GENESEEQPRIME® assay is adept at identifying a wide range of genomic changes. These include single nucleotide variants (SNVs), small insertions and deletions (indels), as well as larger genetic events such as gene amplifications and translocations. Moreover, it evaluates microsatellite instability (MSI) and tumor mutation burden (TMB), making it a comprehensive tool that aids in understanding the genetic factors contributing to a patient’s cancer.

Conducted studies across multiple clinical laboratories in the U.S. have demonstrated the test's high sensitivity, specificity, and reproducibility concerning different types of mutations. This robust validation underscores the assay's intended application in clinical oncology, affirming its capability to deliver reliable results in a real-world setting.

What sets the GENESEEQPRIME® apart is its potential for decentralized deployment. The assay is provided as a ready-to-use IVD kit, facilitating easy integration into local oncology laboratories. This model not only supports standardized implementation but ensures that healthcare facilities worldwide can uphold globally recognized standards in cancer testing.

Additionally, GENESEEQPRIME® is integrated with GENESIS by GENESEEQ®, a proprietary bioinformatics platform that streamlines the analysis and reporting process. This pipeline has been validated across numerous CAP- and CLIA-accredited laboratories, thereby offering a consistent data analysis framework that enhances workflow efficiency in lab settings.

The FDA's clearance is a crucial step for Geneseeq as it propels forward development for multi-regional clinical trials and biomarker-driven pharmaceutical advancements. By establishing a validated testing platform, Geneseeq lays the foundation for future companion diagnostics (CDx) and promotes operational effectiveness across diverse geographical locations.

Geneseeq has not only achieved FDA clearance but has also secured CE-IVD marking in Europe and NMPA approval in China, situating itself at the forefront of the global precision oncology market. Dr. Xue Wu, the CEO of Geneseeq Technology Inc., expressed his enthusiasm, emphasizing that this clearance allows laboratories to provide top-tier genomic profiling using a standardized and regulatory-compliant platform. The end goal is clear: to broaden patient access to precision medicine while driving forward the innovation necessary for enhanced cancer care on a global scale.

About Geneseeq Technology Inc.

Founded as an innovation-driven enterprise, Geneseeq Technology Inc. stands as a global leader in precision oncology. The company specializes in next-generation sequencing technologies aimed at revolutionizing cancer detection, diagnosis, and treatment. With a wide-ranging product line that includes comprehensive genomic profiling for various tumor types and disease monitoring solutions, Geneseeq is committed to empowering healthcare professionals and patients alike.

With its flagship product, the GENESEEQPRIME® tumor profiling assay now FDA-approved, and other diagnostic panels bearing the CE-IVD mark, Geneseeq is poised to expand its impact on the field of oncology. Its capabilities extend to four additional panels with CE-IVD marking and its CanScan® MCED assay, which has received the FDA Breakthrough Device Designation. The company operates from its headquarters in Canada and China, maintaining partnerships with hospitals, academic institutions, and pharmaceutical companies to push the boundaries of precision medicine and expedite therapeutic development.