#China #Nanjing #Geneseeq Technology #NTRK gene fusions #PanTRKare

Geneseeq's PanTRKare™ Receives NMPA Approval

A Groundbreaking Achievement in Cancer Diagnostics

Geneseeq Technology Inc., a leader in precision oncology, has achieved a significant milestone with the approval of its PanTRKare™ NTRK1/NTRK2/NTRK3 Gene Fusion Detection Kit by China's National Medical Products Administration (NMPA). This product is not only the first of its kind in China, but it also stands out as the first next-generation sequencing (NGS)-based pan-solid tumor companion diagnostic test for detecting NTRK gene fusions.

Importance of NTRK Gene Fusions

NTRK gene fusions occur in fewer than 1% of all solid tumors, yet they represent critical actionable oncogenic alterations across multiple types of cancer. Patients with these fusions are likely to benefit from TRK inhibitors, such as Roche's ROZLYTREK®. The introduction of the PanTRKare™ kit will facilitate more precise and tailored treatment options for this specific patient population, enhancing the landscape of cancer care in China.

Rigorous Validation Process

The PanTRKare™ kit underwent extensive clinical validation in a large-scale multi-center study that included seven prominent hospitals, covering 33 tumor types and over 2,400 clinical samples. The results demonstrated the kit's exceptional accuracy, sensitivity, and reproducibility when detecting a wide variety of NTRK fusion variants. More than 200 distinct NTRK fusion variants were identified during the study, establishing PanTRKare™ as one of the most reliable NTRK companion diagnostic tests globally.

This thorough validation ensures that healthcare providers can confidently utilize the PanTRKare™ kit for both routine oncology practices and translational research, thus enhancing the precision of gene fusion detection.

Bridging Clinical Research and Practice

Clinical bridging studies conducted with ROZLYTREK® showed a high level of concordance in test results and comparable objective response rates (ORR) in NTRK fusion-positive patients. This adds to the test's clinical utility, showcasing its ability to improve patient outcomes through targeted therapies. The approval has significant implications for clinicians, as they can now promptly identify patients with NTRK gene fusions and connect them with the most effective treatments available.

Commitment to Innovation in Oncology

Dr. Yang Shao, CEO of Nanjing Geneseeq Technology Inc., emphasized that the NMPA approval signifies a pivotal moment for precision oncology in China. He noted, “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 achievement reflects Geneseeq's ongoing dedication to enhancing patient outcomes through advanced molecular diagnostics.

Furthermore, Geneseeq has committed to ongoing innovation in the realm of oncology diagnostics. The company aims to expand its regulatory collaborations and biopharmaceutical partnerships while emphasizing patient-centered product development to ensure that precision medicine is accessible to a broader audience.

About Geneseeq Technology Inc.

Geneseeq Technology Inc. is at the forefront of precision oncology, utilizing next-generation sequencing (NGS) technologies to revolutionize cancer detection, diagnosis, and treatment. Their offerings include comprehensive genomic profiling, cancer-specific diagnostic panels, minimal residual disease (MRD) monitoring, and multi-cancer early detection (MCED) solutions. The flagship GeneseeqPrime® tumor profiling assay is already FDA-cleared, CE-IVD marked, and now NMPA-approved, further ensuring accessibility across major global markets.

With operations in Canada and China, Geneseeq collaborates with hospitals, academic institutions, and pharmaceutical companies worldwide to advance the field of precision medicine and accelerate the development of biomarker-driven therapies.

The advent of the PanTRKare™ kit marks a new chapter in cancer diagnostics and showcases Geneseeq's commitment to leading the way in precision oncology.