This is the first next-generation sequencing–based pan–solid tumor companion diagnostic test to be approved in China. It is also the first assay to be approved for the detection of NTRK1/2/3 gene fusions.
This NMPA approval was based on findings from a multicenter clinical trial that was conducted at 7 hospitals and included patients with 33 tumor types who contributed a total of 2400 clinical samples. In this study, the PanTRKare assay showed high levels of accuracy, sensitivity, and reproducibility, and demonstrated broad applicability across a variety of solid tumors. The assay successfully detected over 200 unique NTRK fusion variants. Additionally, results from clinical bridging studies investigating entrectinib were highly concordant and demonstrated high overall response rates (ORRs) among patients with NTRK fusion–positive disease.
“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,” Yang Shao, PhD, chief executive officer of Nanjing Geneseeq Technology Inc., stated in a news release. “This milestone reflects Geneseeq’s ongoing commitment to advancing precision oncology and improving outcomes for patients through innovation in molecular diagnostics. 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.”
Where else in the world is entrectinib approved for patients with NTRK fusion–positive disease?
In 2019, the FDA granted accelerated approval to entrectinib for the treatment of adult and pediatric patients at least 12 years of age who have solid tumors harboring an NTRK fusion.2 This approval is specific to patients who have a known acquired resistance mutation, those who have metastatic disease, or those in whom surgical resection is likely to result in severe morbidity and who have progressed on therapy or have no treatment alternatives. This regulatory decision was supported by data from an integrated analysis of the phase 2 STARTRK-2 (NCT02568267), phase 1 STARTRK-1 (NCT02097810), and phase 1 ALKA-372-001 (NCT02097810) trials. The analysis showed an ORR of 57% (95% CI, 43%-71%) in adult patients with NTRK fusion–positive solid tumors (n = 54). The duration of response was at least 6 months in 68% of patients and at least 12 months in 45% of patients. The most common cancers evaluated in the trials were sarcoma, non–small cell lung cancer, mammary analogue secretory carcinoma, breast cancer, thyroid cancer, and colorectal cancer.
In June 2022, the FDA approved FoundationOne CDx, a tissue-based genomic profiling test, for the identification of patients with NTRK fusion–positive cancers who might be appropriate candidates for treatment with entrectinib.3 Furthermore, in January 2023, the regulatory agency approved the FoundationOne Liquid CDx as a companion diagnostic for the identification of patients with NTRK fusion–positive solid tumors who may be candidates for entrectinib therapy but do not have an available tissue sample.4
Moreover, in August 2020, the European Commission approved entrectinib for the treatment of adult and patients at least 12 years of age with solid tumors harboring an NTRK fusion.5 This approval was also supported by data from the STARTRK-2, STARTRK-1, and ALKA-372-001 trials, as well as from the phase 1/2 STARTRK-NG study (NCT02650401), which investigated the efficacy and safety of the agent in pediatric patients.
References
- Geneseeq receives NMPA approval for PanTRKare - China’s first NGS-based pan-solid tumor companion diagnostic kit for NTRK gene fusions. News release. Geneseeq Technology, Inc. November 10, 2025. Accessed November 14, 2025. https://na.geneseeq.com/geneseeq-receives-nmpa-approval-for-pantrkare-chinas-first-ngs-based-pan-solid-tumor-companion-diagnostic-kit-for-ntrk-gene-fusions/
- FDA approves entrectinib for NTRK solid tumors and ROS-1 NSCLC. FDA. August 15, 2019. Accessed November 14, 2025. https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-entrectinib-ntrk-solid-tumors-and-ros-1-nsclc
- US FDA approves Foundation Medicine’s FoundationOne CDx as a companion diagnostic for Roche’s Rozlytrek (entrectinib). News release. Roche. June 9, 2022. Accessed November 14, 2025. https://www.roche.com/media/releases/med-cor-2022-06-09b
- FoundationOne Liquid CDx Receives FDA Approval as a Companion Diagnostic for Rozlytrek (entrectinib). News release. Foundation Medicine. January 4, 2023. Accessed November 14, 2025. https://www.foundationmedicine.com/press-releases/foundationone®liquid-cdx-receives-fda-approval-as-a-companion-diagnostic-for-rozlytrek®-%28entrectinib%29
- Rozlytrek, Roche’s first tumour-agnostic therapy, approved in Europe for people with NTRK fusion-positive solid tumours and for people with ROS1-positive advanced non-small cell lung cancer. News release. Published August 3, 2020. Accessed November 14, 2025. https://www.roche.com/investors/updates/inv-update-2020-08-03
