CDx Archives - Geneseeq Technology Inc. | A Precision Oncology Company /tag/cdx/ We see precision medicine as the future of cancer care. LetтАЩs accelerate precision cancer care, together. Fri, 07 Nov 2025 14:56:05 +0000 en-US hourly 1 https://wordpress.org/?v=6.9.4 /wp-content/uploads/2019/09/geneseeq-fav.png CDx Archives - Geneseeq Technology Inc. | A Precision Oncology Company /tag/cdx/ 32 32 Geneseeq Receives NMPA Approval for PanTRKareтДв – ChinaтАЩs First NGS-Based Pan-Solid Tumor Companion Diagnostic Kit for NTRK Gene Fusions /geneseeq-receives-nmpa-approval-for-pantrkare-chinas-first-ngs-based-pan-solid-tumor-companion-diagnostic-kit-for-ntrk-gene-fusions/ /geneseeq-receives-nmpa-approval-for-pantrkare-chinas-first-ngs-based-pan-solid-tumor-companion-diagnostic-kit-for-ntrk-gene-fusions/#respond Mon, 10 Nov 2025 15:00:31 +0000 /?p=89242 Toronto, Canada тАФ [November 10, 2025] тАФ Geneseeq Technology Inc., a global precision oncology company, today announced its PanTRKareтДв NTRK1/NTRK2/NTRK3 […]

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Toronto, Canada тАФ [November 10, 2025] тАФ Geneseeq Technology Inc., a global precision oncology company, today announced its PanTRKareтДв NTRK1/NTRK2/NTRK3 Gene Fusion Detection Kit has received marketing authorization from ChinaтАЩs National Medical Products Administration (NMPA). The assay is approved as a companion diagnostic (CDx) test for RocheтАЩs ROZLYTREK┬о (entrectinib). This milestone marks ChinaтАЩs 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┬о. PanTRKareтДв 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 PanTRKareтДв 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 PanTRKareтДв 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 PanTRKareтДв, 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.

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Geneseeq partners with Jiangsu Vcare PharmaTech to develop a CDx for NTRK inhibitor in China. /geneseeq-partners-with-jiangsu-vcare-pharmatech-to-develop-a-cdx-for-ntrk-inhibitor-in-china/ /geneseeq-partners-with-jiangsu-vcare-pharmatech-to-develop-a-cdx-for-ntrk-inhibitor-in-china/#respond Wed, 03 Jul 2024 14:26:49 +0000 /?p=88007 July 3, 2024, Toronto – Geneseeq Technology Inc. announced this week its partnership with Jiangsu Vcare PharmaTech to develop a […]

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July 3, 2024, Toronto – Geneseeq Technology Inc. announced this week its partnership with Jiangsu Vcare PharmaTech to develop a companion diagnostic (CDx) kit and advance the product launch of VcareтАЩs pan-neurotrophic tyrosine receptor kinase (NTRK) inhibitor VC004 in China.

VC004 is a highly selective next-generation NTRK inhibitor developed to overcome acquired resistance to first-generation NTRK inhibitors in NTRK fusion-positive cancers. VC004 has shown excellent in vitro and in vivo activities, a manageable safety profile and promising efficacy. Currently, there are no commercially available next-generation NTRK inhibitors in China. The introduction of VC004 is poised to fill this significant gap in the market, offering a novel treatment option for patients.

Dr. Xiaonan Wang, Co-founder and CTO of Geneseeq, stated, тАЬThrough this deep strategic collaboration, we aim to accelerate the development and clinical application of innovative drugs in China. Our commitment is to provide patients with more treatment options, leading to greater survival benefits.”

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