On June 23, 2025, Quanterix Corporation announced that its HD-X Simoa Immunoassay Analyzer received Class 1 Medical Device registration by the Ministry of Food and Drug Safety (MFDS) in South Korea, facilitated by its regional distribution partner, HS Biosystems. This expands the Simoa technology platform into global markets.
Quanterix also established several new global collaborations with laboratories and patient testing centers, strengthening the infrastructure for Alzheimer’s testing. Notably, Rede D’Or, Richet Laboratory (IDOR), the largest integrated healthcare network in Brazil, acquired a Simoa HD-X and implemented P-tau217 and NfL for testing.
IDOR recently published its first paper in Nature Communications on its work to reduce the underdiagnosis of Alzheimer's Disease in Brazil, utilizing Quanterix's technology. These advancements underscore the growing validation and clinical utility of Simoa technology in early disease detection and diagnostics worldwide.
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