Geneseeq's PanTRKare™ Receives NMPA Approval as China's First NGS-Based Pan-Solid Tumor Companion Diagnostic for NTRK Gene Fusions
核心洞察
Geneseeq Technology Inc (搜索). has received NMPA approval for PanTRKare (搜索)™, China's first next-generation sequencing-based pan-solid tumor companion diagnostic test for detecting NTRK1 (搜索)/2/3 gene fusions.
The assay was validated through a comprehensive multi-center clinical study involving seven leading hospitals, 33 tumor types, and more than 2,400 clinical samples, successfully detecting over 200 unique NTRK fusion variants.
PanTRKare (搜索)™ is approved as a companion diagnostic test for Roche's ROZLYTREK® (entrectinib), addressing the clinical need to identify patients with rare NTRK gene fusions who can benefit from targeted TRK (搜索) inhibitor therapy.
Geneseeq Technology Inc (搜索)., a global precision oncology company, announced that its PanTRKare (搜索)™ NTRK1 (搜索)/NTRK2 (搜索)/NTRK3 (搜索) Gene Fusion Detection Kit has received marketing authorization from China's National Medical Products Administration (NMPA). The assay represents a significant milestone as China's first next-generation sequencing (NGS)-based pan-solid tumor companion diagnostic test and the first approved assay specifically designed for detecting NTRK1/2/3 gene fusions.
Targeting Rare but Actionable Oncogenic Alterations
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 (搜索) inhibitors such as ROZLYTREK® (entrectinib), for which PanTRKare (搜索)™ serves as an approved companion diagnostic test. The assay enables accurate, sensitive detection of NTRK1 (搜索)/2/3 fusions across diverse tumor types, bringing precision medicine to patients who harbor this rare but clinically important type of mutation.
Comprehensive Clinical Validation Demonstrates Robust Performance
The PanTRKare (搜索)™ kit underwent rigorous validation 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, successfully detecting more than 200 unique NTRK fusion variants during the validation study.
This comprehensive validation establishes PanTRKare (搜索)™ as one of the most clinically robust NTRK companion diagnostic tests globally, ensuring confidence in both routine oncology and translational research settings.
Clinical Utility Confirmed Through Bridging Studies
Clinical bridging studies with ROZLYTREK® showed high concordance of testing results and comparable objective response rates (ORR) among NTRK fusion-positive patients. These results underscore 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 (搜索)™, clinicians across China can now access an accurate, reliable tool to identify patients with NTRK gene fusions and connect them to effective targeted therapies," said Dr. Yang Shao, CEO of Nanjing Geneseeq Technology Inc (搜索). "This milestone reflects Geneseeq's ongoing commitment to advancing precision oncology and improving outcomes for patients through innovation in molecular diagnostics."
Expanding Precision Medicine Access
Dr. Shao emphasized that 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 patients.
Geneseeq Technology Inc (搜索). is a research-driven global leader in precision oncology, pioneering NGS technologies to transform cancer detection, diagnosis, and treatment. The company's portfolio spans comprehensive genomic profiling across tumor types, cancer-specific diagnostic panels, minimal residual disease monitoring, and multi-cancer early detection solutions.
The company's flagship GeneseeqPrime® tumor profiling assay has achieved regulatory approval across major markets, being FDA-cleared, CE-IVD marked, and NMPA-approved. Additionally, four other Geneseeq panels have received CE-IVD marking, and its multi-cancer early detection assay CanScan® has been granted FDA Breakthrough Device Designation.