Billerica, Mass.– Quanterix Corporation has announced a significant expansion of its international presence as it continues to drive innovation in early disease detection, particularly for Alzheimer’s disease. The company’s flagship HD-X Simoa Immunoassay Analyzer has been officially registered as a Class 1 Medical Device in South Korea by the country’s Ministry of Food and Drug Safety (MFDS), with the assistance of Quanterix’s local distribution partner, HS Biosystems. This milestone marks a key entry into the South Korean clinical diagnostics market and strengthens the global footprint of the company’s Simoa® technology platform.
The Simoa platform is designed to detect disease-related biomarkers in blood, serum, or plasma at ultra-low concentrations, far below what conventional diagnostic technologies can measure. Its high sensitivity and capacity for multi-marker testing make it a valuable tool for clinicians seeking earlier and more accurate diagnosis of diseases like Alzheimer’s, where early intervention can significantly alter the course of treatment and quality of life.
Quanterix CEO Masoud Toloue highlighted the platform’s unique positioning across the diagnostic spectrum. He explained that while most instruments on the market are limited to either research or clinical diagnostics, Quanterix bridges the gap by supporting the full pipeline—from biomarker discovery and clinical trials to diagnostic testing. He noted that this comprehensive utility has made Simoa a critical component of many emerging Alzheimer’s diagnostics currently being developed or implemented.
As part of its broader strategy, Quanterix has entered into several new global collaborations with diagnostic laboratories and testing centers. These partnerships aim to strengthen the infrastructure for Alzheimer’s testing and expand access to its technologies. In the United States, ARUP Laboratories has launched a blood test for phosphorylated tau 217 (P-tau217), a biomarker closely associated with Alzheimer’s pathology. The test uses Quanterix’s SP-X® platform and assay kits developed with antibody technology licensed from Eli Lilly and Company.
In another initiative, Neurogen Biomarking has introduced an at-home blood biomarker collection test that also measures P-tau217, offering a more accessible option for individuals experiencing early memory loss. The test relies on Quanterix’s highly sensitive technology for laboratory analysis. In Australia, NSW Health Pathology, the country’s largest public pathology service, has validated neurofilament light (NfL) for clinical testing using the Simoa platform.
In Brazil, Quanterix’s technology is already making an impact through a partnership with Rede D’Or’s Richet Laboratory. The laboratory was the first in Brazil to acquire a Simoa HD-X Analyzer and implement P-tau217 and NfL testing. Their work was recently published in Nature Communications, demonstrating the utility of these biomarkers in addressing underdiagnosis of Alzheimer’s in the country. Luis Eduardo da Silva Santos, a scientist at the Rede D’Or Institute for Research and Education, emphasized the importance of making these tests more affordable and locally accessible. He noted that their research has laid the groundwork for widespread use of the Simoa kits in Brazil.
Quanterix’s global expansion and growing network of partners come at a time when early detection of Alzheimer’s is more important than ever. Studies show that the biological changes associated with Alzheimer’s can begin as early as 20 years before symptoms appear. By enabling earlier diagnosis, Quanterix aims to give patients a better chance of receiving timely interventions, potentially slowing the progression of a disease that remains one of the most challenging health threats of the modern age.
