Regulatory Milestone Expands Access to Blood-Based Neurology Biomarker Testing in China

Quanterix Corporation (Billerica, MA, USA) and Innovita Biological Technology Co., Ltd. (Beijing, China) announced regulatory approvals that expand access to Quanterix SIMOA technology and neurology biomarker testing in China. The commercialization arrangement, initially formed in 2024, combines Quanterix’s ultra-sensitive biomarker detection technology with Innovita’s diagnostics development, regulatory, and commercialization capabilities in the Chinese market. 

Innovita has now received National Medical Products Administration (NMPA) approval for the Quanterix HD-X and SR-X instruments, along with testing kits for four biomarkers relevant to neurological disease: p-Tau 217, GFAP, p-Tau 181, and NfL.

Image: NMPA approvals for Quanterix HD-X and SR-X instruments and four neurology biomarker assays expand access to ultrasensitive blood-based testing in China (Photo courtesy of Quanterix Corporation)

SIMOA is an ultra-sensitive digital immunoassay technology that enables proteins to be quantified at the single-molecule level in blood, serum, and plasma. The technology is designed to detect biomarkers at concentrations far below traditional limits of quantification. This capability addresses challenges associated with measuring low-abundance biomarkers, including p-Tau 217, that may be difficult to detect using conventional immunoassay approaches.

The four biomarkers provide complementary insights into Alzheimer’s disease pathology, neurodegeneration, and neuroinflammation. Their use supports applications across the diagnostic continuum, including early screening, disease monitoring, and prognostic assessment. The expanding neurology biomarker portfolio is also intended to support multi-analyte approaches that may provide a more comprehensive view of disease biology than individual biomarkers alone.

Innovita is planning regulatory submissions for additional Quanterix biomarker diagnostic kits in China. Its diagnostic development and commercialization capabilities are expected to support the integration of SIMOA-powered biomarker testing into clinical practice in China. Innovita may also expand into additional neurodegenerative and infectious disease areas, broadening potential applications for SIMOA-powered diagnostics in the Chinese market and beyond.

“Alzheimer’s disease can progress quietly for years – too often. Families only get answers after symptoms have progressed and drastically changed their lives. 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,” said Xiujie Zhang, Chief Executive Officer of Innovita.

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