Quanterix and Innovita Expand IVD Access in China with National Medical Products Administration Approvals
Business Wire•07/10/2026•08:00 ET
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Key Highlights
- ➤NMPA approves Quanterix HD-X and SR-X instruments in China
- ➤Four neurology biomarker kits approved: p-Tau 217, GFAP, p-Tau 181 and NfL
- ➤Innovita plans additional Quanterix biomarker-kit regulatory submissions in China
- ➤Innovita may expand SIMOA-powered diagnostics into neurodegenerative and infectious diseases
Expert Statements
Xiujie Zhang, Chief Executive Officer of Innovita
“Alzheimer’s disease can progress quietly for years – too often. Families only get answers after symptoms have progressed and drastically changed their lives”
Xiujie Zhang, Chief Executive Officer of Innovita
“By partnering with Quanterix, we're bringing ultra-sensitive blood-based biomarker testing to China, supporting earlier, more informed clinical decision-making and expanding access to advanced diagnostics for patients and communities who need it most.”
Everett Cunningham, Chief Executive Officer of Quanterix
“Alzheimer’s disease places an enormous burden on patients and families, and earlier, more accessible testing can help clinicians make more informed decisions sooner.”
Everett Cunningham, Chief Executive Officer of Quanterix
“Our commercialization arrangement with Innovita is a critical step toward expanding access to ultra-sensitive protein biomarker testing globally and underscores the momentum of our strategy to bring SIMOA®powered diagnostics into large, high-impact IVD markets through strong regional partners.”
Quanterix and Innovita Expand IVD Access in China with National Medical Products Administration Approvals
NMPA approvals for Quanterix SIMOA(®) instruments and key neurology biomarker assays advance access to ultra-sensitive blood-based testing in China
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