Quanterix gains Chinese regulatory approval for neurology testing kits via Innovita
Quanterix announced that China's National Medical Products Administration approved its HD‑X and SR‑X instruments and four neurology biomarker kits. The approvals, granted to its partner Innovita Biological, cover p‑Tau 217, GFAP, p‑Tau 181 and NfL tests used in Alzheimer’s disease diagnostics. The companies formed a commercialization partnership in 2024 to bring Quanterix’s ultra‑sensitive SIMOA technology to the Chinese market.
Why it matters
The approval opens a new revenue stream for Quanterix by allowing commercial sales of its IVD kits in China, a large and growing diagnostics market. The company expects the partnership to accelerate clinical adoption of its blood‑based biomarker tests in the region.
Key facts
- 1China’s NMPA approved Quanterix’s HD‑X and SR‑X instruments and testing kits for four neurological disease biomarkers. tradingview.com
- 2The approved kits target p‑Tau 217, GFAP, p‑Tau 181 and NfL biomarkers used in Alzheimer’s disease diagnostics. tradingview.com
- 3Innovita Biological received the regulatory approval on behalf of Quanterix. investing.com
- 4Quanterix and Innovita formed a commercialization arrangement in 2024 to market the technology in China. investing.com
Summary written by AlphAI from 2 of 2 sources. Not investment advice. Figures are as stated by the linked sources.