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Quanterix and Innovita Expand IVD Access in China with National Medical Products Administration Approvals

  • Quanterix & Innovita received NMPA approval in China for Quanterix HD-X & SR-X instruments & four neurology biomarker testing kits.
  • Approved biomarkers include p-Tau 217, GFAP, p-Tau 181, & NfL to support Alzheimer's disease diagnosis & monitoring.
  • The commercial arrangement combines Quanterix's SIMOA ultra-sensitive detection technology with Innovita's regulatory & commercial capabilities.
  • SIMOA technology enables single-molecule protein quantification to detect low-abundance biomarkers that conventional immunoassays miss.
  • Innovita plans future regulatory submissions for additional Quanterix biomarker kits & aims to expand into other neurodegenerative & infectious diseases.
  • The partnership aims to facilitate earlier clinical decision-making & broader access to blood-based diagnostics in the Chinese market.