Quanterix and Innovita win China approval for Alzheimer's blood tests

Quanterix Corporation (NASDAQ: QTRX) and Innovita Biological Technology Co., Ltd. (SSE: 688253) announced that China's National Medical Products Administration (NMPA) has approved Quanterix's HD-X and SR-X instruments, along with four neurology biomarker testing kits, for use in the Chinese market.

The approved biomarker assays target p-Tau 217, GFAP, p-Tau 181, and NfL — proteins associated with Alzheimer's disease pathology, neurodegeneration, and neuroinflammation. The instruments and kits use Quanterix's Single Molecule Array (Simoa) technology, which is designed to detect proteins at concentrations below the limits of conventional immunoassay methods.

The commercialization arrangement between the two companies was initially formed in 2024. Under the arrangement, Innovita handles diagnostics development, regulatory submissions, and commercialization in China, while Quanterix provides the underlying detection technology.

"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 China, supporting earlier, more informed clinical decision-making."

Everett Cunningham, Quanterix's chief executive officer, said the arrangement with Innovita "is a critical step toward expanding access to ultra-sensitive protein biomarker testing globally."

Innovita said it plans to submit additional Quanterix biomarker diagnostic kits for NMPA review and may expand the scope of applications to include other neurodegenerative and infectious diseases. Innovita, founded in 2006 and listed on the Shanghai STAR Market, currently sells more than 50 in vitro diagnostic products across more than 70 countries.

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