Geneseeq received China NMPA approval for its NIFTY-grade NTRK fusion detection kit (PanTRKare assay) as a companion diagnostic, enabling patient selection for Vcare PharmaTech’s TRK inhibitor velmarto. The decision highlights how sequencing-based assays are being formalized into regulatory pathways that directly influence access to targeted therapeutics. For biotech developers, the ruling is a reminder that CDx readiness can be as strategically important as drug efficacy, especially in biomarker-defined oncology segments where testing availability can become a gating factor for real-world adoption.