Quanterix HD-X Simoa gets Class 1 Medical Device registration in South Korea

Quanterix (QTRX) announced that the HD-X Simoa Immunoassay Analyzer has received Class 1 Medical Device registration by the Ministry of Food and Drug Safety in South Korea through its regional distribution partner, HS Biosystems. Quanterix has established several new global collaborations with laboratories and patient testing centers, further strengthening the infrastructure for Alzheimer’s testing and reinforcing its clinical utility. These recent collaborations include: ARUP Laboratories – a national reference laboratory that recently launched a blood test for phosphorylated tau 217 to assist in identifying whether cognitive decline symptoms in patients ages 60 years and older are related to Alzheimer’s disease pathology. ARUP’s test will be performed on Quanterix’s SP-X platform with the Quanterix Simoa assay kit, which uses P-tau217 antibody technology licensed from Eli Lilly and Company. Neurogen Biomarking – the world’s first ecosystem for memory loss with end-to-end patient support recently announced an easy-to-use at-home blood biomarker collection test that can measure phosphorylated tau 217, a specific marker for Alzheimer’s disease pathology and MCI, using Quanterix’s highly sensitive technology. NSW Health Pathology – the largest public pathology service in Australia, has validated NfL for patient testing.