Quanterix and Innovita Expand IVD Access in China with National Medical Products Administration Approvals
Quanterix and its China partner Innovita received NMPA approvals for the SIMOA HD-X and SR-X instruments plus testing kits for four neurology biomarkers: p-Tau 217, GFAP, p-Tau 181 and NfL. The approvals expand access to ultra-sensitive blood-based biomarker testing in China, targeting the growing Alzheimer's disease diagnostic market under a commercialization arrangement formed in 2024.
Key figures
- Drug Name
- SIMOA HD-X and SR-X instruments; biomarker kits for p-Tau 217, GFAP, p-Tau 181 and NfL
- Regulator
- National Medical Products Administration (NMPA), China
- Approved biomarkers
- ["p-Tau 217","GFAP","p-Tau 181","NfL"]
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