Quanterix and Innovita Expand IVD Access in China with National Medical Products Administration Approvals
The approvals cover two instruments and four neurology biomarker testing kits under the commercialization arrangement formed in 2024.
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NMPA approvals for Quanterix SIMOA® instruments and key neurology biomarker assays advance access to ultra-sensitive blood-based testing in
Initially formed in 2024, the commercialization arrangement combines Quanterix’s ultra-sensitive biomarker detection technology with Innovita’s diagnostics development, regulatory and commercialization capabilities in
Together, these approvals establish a broader SIMOA®-powered neurology biomarker portfolio in
“Alzheimer’s disease can progress quietly for years – too often. Families only get answers after symptoms have progressed and drastically changed their lives,” said Xiujie Zhang, Chief Executive Officer of Innovita. “By partnering with Quanterix, we're bringing ultra-sensitive blood-based biomarker testing to
Quanterix’s SIMOA® technology delivers ultra-sensitive digital immunoassay technology that enables proteins to be quantified at the single-molecule level in blood, serum, and plasma. By enabling detection of biomarkers at concentrations far below traditional limits of quantification (LoQ), SIMOA® is designed to address the challenge of measuring low-abundance biomarkers that may be difficult to detect using traditional immunoassay approaches. Its expanding neurology biomarker portfolio includes markers associated with Alzheimer’s disease pathology, neurodegeneration and neuroinflammation, supporting the development of multi-analyte approaches that may provide a more comprehensive view of disease biology than individual biomarkers alone.
“Alzheimer’s disease places an enormous burden on patients and families, and earlier, more accessible testing can help clinicians make more informed decisions sooner,” said Everett Cunningham, Quanterix Chief Executive Officer. “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.”
Innovita is planning to make regulatory submissions for additional Quanterix biomarker diagnostic kits in
About Quanterix
Quanterix is a global leader in precision biomarker science, making biology measurable to deliver earlier insights and support breakthroughs in disease research, diagnostics, and drug development. Its SIMOA® technology delivers industry-leading sensitivity, allowing researchers to detect and quantify biomarkers in blood and other fluids at concentrations far below traditional limits. Through the acquisition of Akoya Biosciences, Quanterix Spatial solutions deliver high-plex, quantitative protein analysis in tissue at single-cell resolution. Combined with Accelerator Laboratory services, Quanterix gives researchers the tools and expertise to translate discovery into precision diagnostics. Learn more at www.quanterix.com.
About Innovita
Founded in 2006 and listed on the Shanghai STAR Market (Stock: 688253.SH), Innovita Biotechnology is a leading company in rapid infectious disease diagnostics. Guided by the mission "Diagnostics, Wherever Care is Needed," Innovita builds upon six core technology platforms — antigen-antibody preparation, viral culture, colloidal gold, ELISA, fluorescence chromatography, and immunofluorescence — to become a globally recognized brand in multiplex pathogen detection.
The company's portfolio of 50+ IVD rapid tests spans respiratory pathogens, tropical diseases, hepatitis and sexually transmitted infections, maternal/TORCH screening, and gastrointestinal infections. CE marked and ISO 13485 certified, Innovita products are sold in 70+ countries. The company operates Class 100,000 cleanroom manufacturing facilities in China, holds multiple national invention patents, and is actively pursuing IVDR and US FDA registration to accelerate international growth. Learn more at www.innovitaivd.com.
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