Addressing Unmet Clinical Needs: Shedding Light on Rare Mutations
NTRK gene family fusions occur in less than 1% of all solid tumors, but represent one of the most actionable oncogenic alterations across cancer types. Patients harboring these fusions can benefit from TRK inhibitors such as ROZLYTREK®. PanTRKare enables accurate, sensitive detection of NTRK1/2/3 fusions across diverse tumor types, bringing precision medicine to patients who harbor this rare but important type of mutations.

Robust Clinical Validation Across 33 Tumor Types and 2,400+ Cases
The PanTRKare kit was rigorously validated through a large-scale multi-center clinical study involving seven leading hospitals, 33 tumor types and more than 2,400 clinical samples. The assay demonstrated high accuracy, sensitivity, reproducibility and broad applicability across a wide spectrum of solid tumors, having successfully detected more than 200 unique NTRK fusion variants in this study. This comprehensive validation establishes PanTRKare as one of the most clinically robust NTRK CDx test globally, ensuring confidence in both routine oncology and translational research settings.

Empowering Targeted Therapies Through Collaborative CDx Development
Clinical bridging studies with ROZLYTREK® showed high concordance of testing results, as well as comparable objective response rate (ORR) among NTRK fusion–positive patients. This result underscores the test’s clinical utility and its pivotal role in advancing precision medicine for patients with rare genetic alterations.

“With the NMPA approval of PanTRKare, clinicians across China can now access an accurate, reliable tool to identify patients with NTRK gene fusions and connect them to effective targeted therapies. This milestone reflects Geneseeq’s ongoing commitment to advancing precision oncology and improving outcomes for patients through innovation in molecular diagnostics,” said Dr. Yang Shao, CEO of Nanjing Geneseeq Technology Inc.. “Geneseeq will continue to drive innovation across oncology diagnostics through global regulatory collaborations, biopharma partnerships, and patient-centered product development, advancing its mission to make precision medicine accessible to all.”

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 countries and regions. 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.

The post Geneseeq Receives NMPA Approval for PanTRKare™ – China’s First NGS-Based Pan-Solid Tumor Companion Diagnostic Kit for NTRK Gene Fusions appeared first on Geneseeq Technology Inc. | A Precision Oncology Company.

Toronto, Canada – September 2, 2025 – 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 vitrodiagnostic (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.

The post GeneseeqPrime® Gains FDA 510(k) Clearance appeared first on Geneseeq Technology Inc. | A Precision Oncology Company.