Geneseeq received marketing authorization from China’s National Medical Products Administration for its PanTRKare NTRK fusion detection kit as a companion diagnostic for Roche’s Rozlytrek (entrectinib). The approval is China’s first sequencing‑based pan‑solid tumor CDx and the first NMPA clearance for an NTRK fusion assay. The PanTRKare assay was validated in a multi‑center clinical study across seven hospitals, 33 tumor types and over 2,400 samples, demonstrating broad applicability and the detection of more than 200 unique NTRK fusion variants. Geneseeq positioned the test as enabling identification of rare NTRK fusions (<1% of solid tumors) that predict benefit from TRK inhibitors. This regulatory milestone expands access to precision oncology testing in China and underscores the role of NGS‑based diagnostics as CDx tools for tumor‑agnostic targeted therapies.
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