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┬о. 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┬о showed high concordance of testing results, as well as comparable objective response rate (ORR) among NTRK fusionтАУpositive patients. This result underscores the testтАЩs clinical utility and its pivotal role in advancing precision medicine for patients with rare genetic alterations.

тАЬWith 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 GeneseeqтАЩs ongoing commitment to advancing precision oncology and improving outcomes for patients through innovation in molecular diagnostics,тАЭ said Dr. Yang Shao, CEO of Nanjing Geneseeq Technology Inc.. тАЬGeneseeq 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.тАЭ

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 companyтАЩs flagship GeneseeqPrime┬о 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┬о 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 PanTRKareтДв – ChinaтАЩs First NGS-Based Pan-Solid Tumor Companion Diagnostic Kit for NTRK Gene Fusions appeared first on Geneseeq Technology Inc. | A Precision Oncology Company.

International oncology guidelines, such as those from NCCN, ESMO and CSCO, recommend the use of liquid biopsy as an alternative when tumor tissue samples are inaccessible. Currently, most approved NGS IVD kits on ChinaтАЩs market are designed for tumor tissue testing. GeneseeqтАЩs NGS liquid biopsy kit is capable of identifying mutations in multiple key tumor driver genes in a single test with world-leading detection performance, and provides companion diagnostics for a range of targeted therapies. This kit is expected to fill the gap and marks a pioneering step in ChinaтАЩs precision oncology healthcare.

The kit uses advanced non-invasive liquid biopsy testing technology to accurately identify tumor-driving mutations by analyzing circulating tumor DNA (ctDNA) in the blood, without the need for tumor tissue samples. As a valuable complement to traditional tumor tissue testing, it greatly assists clinicians for timely treatment-decision making and drives personalized precision medicine.

Dr. Xiaonan Wang, CTO of Geneseeq, stated, тАЬThis kit is the third NGS IVD product from Geneseeq to enter the NMPA Innovative Medical Device program, following the previous NMPA approvals of the тАШEGFR/ALK/ROS1/BRAF/KRAS/HER2 Mutation Detection KitтАШ and the тАШGeneseeqPrime NGS TMB Testing KitтАШ for tumor tissue testing. From 6 genes to 400+ genes, from tumor tissue to liquid biopsy testing, Geneseeq has always been patient-need driven, continuously exploring the translation of cutting-edge technologies into clinical practice. The successful inclusion of this kit in the Innovative Medical Device program highlighted GeneseeqтАЩs R&D strength and innovation capability in the field of precision medicine. We believe that with the continuous technology innovation and clinical application, more and more patients will benefit from the technological advancements for life quality improvement.тАЭ

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This NSCLC TMB kit entered the NMPA special examination and approval procedures for Breakthrough Medical Devices in January 2020. With the NMPA approval, this kit is used for in vitro qualitative detection of TMB in FFPE tissue samples from patients with EGFR/ALK-negative non-squamous NSCLC. This is the first next-generation sequencing (NGS)-based TMB test kit approved in China with a large gene panel covering 425 cancer-associated genes (GENESEEQPRIME). TMB is a predictive biomarker for the efficacy of immune checkpoint inhibitor therapy.

Prior to this, Geneseeq already had one NGS-based CDx kit for NSCLC, ESSENCARE (EGFR/ALK/ROS1/BRAF/KRAS/HER2 mutation testing kit), approved by the NMPA through the Breakthrough Medical Devices pathway. GENESEEQPRIME was also CE-IVD marked by the European Medicines Agency in August 2023 for detecting single nucleotide variants, gene amplifications/deletions, translocations, TMB, and microsatellite instability in patients with solid tumors.

тАЬThis approval will significantly benefit the clinical implementation of immunotherapy in China with a standardized TMB assessment assay,тАЭ Dr. Yang Shao, founder and CEO of Geneseeq Group, said in a statement.

The post GENESEEQ RECEIVES CHINESE NMPA APPROVAL FOR LUNG CANCER TUMOR MUTATIONAL BURDEN NGS TEST KIT appeared first on Geneseeq Technology Inc. | A Precision Oncology Company.