Quanterix and Innovita win NMPA approvals for China IVD access

, Ltd. SH), a leading in vitro diagnostics company in China, today announced regulatory approvals that advance access to the Quanterix SIMOA(®) technology and neurology biomarker testing in the Chinese market. 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 China. Innovita has now received National Medical Products Administration (NMPA) approval for the Quanterix HD-X and SR-X instruments, as well as testing kits for four biomarkers relevant to neurological disease: p-Tau 217, GFAP, p-Tau 181 and NfL.

Together, these approvals establish a broader SIMOA(®)-powered neurology biomarker portfolio in China and represent an important step toward expanding access to blood-based biomarker testing as the Alzheimer’s disease diagnostic and treatment landscape continues to evolve. The four biomarkers provide complementary insights into Alzheimer’s disease pathology, neurodegeneration and neuroinflammation, supporting applications across the diagnostic continuum, from early screening to disease monitoring and prognostic assessment.

As clinical practice increasingly shifts toward earlier identification and evaluation of Alzheimer’s disease, highly sensitive blood-based testing becomes increasingly important. Biomarkers such as p-Tau 217 can be present at very low concentrations, creating sensitivity challenges for conventional immunoassay technologies. SIMOA(® )ultra-sensitive analytical capabilities help address these challenges, supporting more informed clinical decision-making across the continuum of care. “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. ” 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. ” Innovita is planning to make regulatory submissions for additional Quanterix biomarker diagnostic kits in China.

Innovita’s diagnostic development and commercialization capabilities will support the integration of SIMOA(® )powered biomarker testing into clinical practice in China, helping bring advanced blood-based Alzheimer’s disease diagnostic closer to routine patient care. Looking ahead, Innovita may also expand into additional neurodegenerative diseases as well as infectious diseases, broadening the potential applications of SIMOA(® )powered diagnostics in the Chinese market and beyond. To learn more about Innovita, visit ( ).

To learn more about Quanterix, visit 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. 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.

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