- Quanterix Corporation's (QTRX, Financial) HD-X Simoa Immunoassay Analyzer is now a recognized Class 1 Medical Device in South Korea.
- The Simoa technology enhances biomarker detection, advancing Alzheimer's diagnostics globally.
- Recent collaborations strengthen Quanterix's infrastructure for Alzheimer's testing and diagnostics.
Quanterix Corporation (QTRX), renowned for its ultrasensitive biomarker detection technology, has achieved a significant milestone with the Class 1 Medical Device registration of its HD-X Simoa Immunoassay Analyzer by the Ministry of Food and Drug Safety in South Korea. This development comes in collaboration with its regional distribution partner, HS Biosystems, marking a crucial expansion of the Simoa® technology platform into global markets.
The Simoa platform is designed to deliver highly sensitive biomarker detection in blood, serum, or plasma, exceeding the sensitivity of traditional measurement platforms. This technology provides clinicians with minimally invasive tools to enhance diagnostic accuracy, particularly in the early detection of neurodegenerative diseases such as Alzheimer's.
Quanterix has recently established several global collaborations to bolster Alzheimer's testing infrastructure. ARUP Laboratories, a prominent national reference lab, launched a blood test for phosphorylated tau 217 (P-tau217) using Quanterix's SP-X® platform. Similarly, Neurogen Biomarking introduced an at-home blood biomarker collection test, also utilizing Quanterix technology to detect P-tau217.
In Australia, NSW Health Pathology has validated the use of NfL for patient testing, while Rede D’Or's Richet Laboratory (IDOR) in Brazil has implemented both P-tau217 and NfL testing. IDOR's work, published in Nature Communications, aims to reduce the underdiagnosis of Alzheimer's disease in Brazil, showcasing the clinical utility of Quanterix's cutting-edge technology.
According to research, early signs of Alzheimer's disease may begin decades before symptoms manifest. With the Simoa platform, researchers and clinicians are equipped with crucial insights for early-stage diagnosis, potentially offering patients access to treatments before the disease advances significantly.
For further information on Quanterix’s innovations and partnerships, visit their official website.
