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Breakthrough Dual NMPA IVD Approvals – Advancing Precision in Hematologic Cancer Management! The Sniper Digital PCR System and BCR-ABL1 (p210) %IS Detection Kit have officially obtained NMPA Class III Medical Device Registration and IVD Reagent Certification (Certificates: 国械注准20253221148, 国械注准20253401817), delivering higher sensitivity and standardized solutions for clinical molecular testing.
📍 Stopping Treatment with Greater Reassurance – Ultra-high sensitivity meets TFR requirements, reducing relapse risk
📍 More Reliable Follow-up – Strong consistency in long-term monitoring, with greater comparability across multiple centers
📍 Earlier Relapse Detection – 1–2 monitoring cycles earlier than qPCR
📍 More Standardized Clinical Practice – Results presented intuitively, with clearer alignment to international guidelines
Enabling hematologic cancer care that is more precise, more reliable, and more reassuring—empowering physicians and patients to move confidently toward sustained remission and improved quality of life.