Geneseeq Receives NMPA Approval for PanTRKare™ - China's First NGS-Based Pan-Solid Tumor Companion Diagnostic Kit for NTRK Gene Fusions
TORONTO, Nov. 10, 2025 /CNW/ - Geneseeq Technology Inc., a global precision oncology company, today announced its PanTRKare™NTRK1/NTRK2/NTRK3 Gene Fusion Detection Kit has received marketing authorization from China's National Medical Products Administration (NMPA). The assay is approved as a companion diagnostic (CDx) test for Roche's ROZLYTREK® (entrectinib). This milestone marks China's first next-generation sequencing (NGS)-based pan-solid tumor NGS CDx test, and it is also the first approved assay for detecting NTRK1/2/3 gene fusions.
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."
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.
SOURCE Geneseeq Technology Inc.
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