TORONTO, Canada – August 11, 2026 – Geneseeq Technology Inc., a global precision oncology company, announced that its PanTRKare™ NTRK1/NTRK2/NTRK3 Gene Fusion Detection Kit has received approval from China’s National Medical Products Administration (NMPA) as a companion diagnostic (CDx) for VELMARTO® (eratrectinib), a TRK-targeted therapy developed by Jiangsu Vcare PharmaTech for patients with NTRK fusion-positive solid tumors in China.
This marks PanTRKare™’s third NMPA-approved CDx application for an NTRK-targeted therapy, building on Geneseeq’s earlier collaborations with Roche for ROZLYTREK® (entrectinib) and Zai Lab for AUGTYRO™ (repotrectinib). Granted under NMPA registration certificate No. 20253402191, the latest approval further broadens PanTRKare™’s role in identifying patients who may benefit from matched TRK-targeted therapies.
PanTRKare™ as a Companion Diagnostic for VELMARTO®
PanTRKare™ is Geneseeq’s NGS-based companion diagnostic designed to detect NTRK1/2/3 gene fusions across solid tumors. By identifying patients with NTRK fusion-positive tumors, the assay supports biomarker-guided treatment decisions and helps connect eligible patients with matched TRK-targeted therapies.
VELMARTO® (eratrectinib), developed by Jiangsu Vcare PharmaTech, is a next-generation TRK inhibitor approved in China for patients with NTRK fusion-positive solid tumors. With this latest NMPA approval, PanTRKare™ can now be used as a companion diagnostic to help identify patients who may be eligible for VELMARTO® treatment.
NTRK gene fusions are rare but clinically actionable molecular alterations that may occur across multiple tumor types. Because these fusions are uncommon, diverse, and often complex, accurate molecular testing is essential to support patient identification and appropriate use of TRK-targeted therapies.
Clinical bridging data showed that the objective response rate observed among patients identified as NTRK fusion-positive by PanTRKare™ was highly consistent with the overall results of the VELMARTO® clinical study. These findings further support the assay’s stability and consistency as a companion diagnostic in this therapeutic setting.
Three NMPA-Approved CDx Applications for PanTRKare™
The latest approval extends PanTRKare™’s companion diagnostic application to a third TRK-targeted therapy. PanTRKare™ was first approved as a CDx for ROZLYTREK® (entrectinib) through Geneseeq’s collaboration with Roche and was subsequently approved to support AUGTYRO™ (repotrectinib) through its collaboration with Zai Lab. It is now also approved as a CDx for VELMARTO® (eratrectinib), developed by Jiangsu Vcare PharmaTech.
Together, these three NMPA-approved CDx applications highlight PanTRKare™’s ability to support multiple TRK-targeted therapies and broaden its clinical utility in identifying patients with NTRK fusion-positive solid tumors.
PanTRKare™ was previously validated in a large-scale multicenter clinical study involving more than 2,400 clinical samples across 33 tumor types, successfully detecting over 200 unique NTRK fusion variants. Together with its expanding CDx applications, these data support the assay’s accuracy, reproducibility, and applicability in clinical practice.
Geneseeq remains committed to advancing precision oncology through regulatory-grade molecular diagnostics, companion diagnostic development, and collaborative partnerships with pharmaceutical companies.
About Geneseeq
Geneseeq Technology Inc. is a global precision oncology company specializing in next-generation sequencing (NGS)-based cancer genomic profiling, molecular diagnostics, and companion diagnostic (CDx) development. The company provides comprehensive genomic profiling, pan-cancer and cancer-specific testing, minimal residual disease (MRD) monitoring, multi-cancer early detection (MCED) solutions, and NGS-based IVD and CDx assays to support biomarker-guided cancer care.
With headquarters in Canada and China, Geneseeq operates CAP-accredited and CLIA-certified laboratories and partners with hospitals, academic institutions, and biopharmaceutical companies worldwide. Through its expertise in oncology molecular diagnostics, clinical genomics, translational research, and CDx collaboration, Geneseeq supports precision medicine, targeted therapy selection, and biomarker-driven drug development for cancer patients.
