Press release summary
Quanterix and Innovita said Oct. 7 that China’s National Medical Products Administration has approved the Quanterix HD-X and SR-X instruments along with four neurology biomarker test kits.
The approvals cover assays for phosphorylated tau 217, glial fibrillary acidic protein, phosphorylated tau 181 and neurofilament light chain. The tests use Quanterix’s single-molecule array, or SIMOA, technology to measure low-abundance proteins in blood, serum and plasma. Innovita is handling diagnostic development, regulatory work and commercialization in China under an arrangement established in 2024.
The approved biomarkers can provide complementary information about Alzheimer’s disease pathology, neurodegeneration and neuroinflammation. Quanterix and Innovita said the portfolio is intended to support uses ranging from early evaluation to disease monitoring and prognosis. Innovita plans additional regulatory submissions, but those products have not yet been approved.
For clinical laboratory readers, the decision expands access to a highly sensitive digital immunoassay platform in a major diagnostic market. Laboratories considering the systems will still need to assess local labeling, workflow requirements, quality controls and clinical-use criteria for each approved assay.
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