Quanterix and Innovita announce Chinese approvals for Simoa instruments and neurology assays
Published in Brain/Neurology, Tools.
October 7, 2026
Quanterix and Innovita announced Chinese regulatory approvals for two Simoa instruments and four neurological biomarker testing kits. According to the companies, Innovita received National Medical Products Administration approval for the HD-X and SR-X instruments and assays for p-Tau 217, GFAP, p-Tau 181 and NfL.
The announcement expands their commercialization arrangement established in 2024. Quanterix supplies ultra-sensitive biomarker detection technology, while Innovita contributes diagnostics development, regulatory submissions and commercialization capabilities in China.
The update concerns access to laboratory instruments and biomarker assays in the Chinese market. It should not be interpreted as an approval in Canada or as evidence that any one blood biomarker, used alone, can provide a definitive neurological diagnosis. Interpretation depends on the assay’s authorized use and the patient’s clinical context.
Source: Quanterix–Innovita announcement via Business Wire, October 7, 2026.