US-based Quanterix Corporation has secured Class 1 Medical Device registration from South Korea's Ministry of Food and Drug Safety (MFDS) for its HD-X Simoa Immunoassay Analyzer, marking a significant expansion of ultrasensitive biomarker detection technology into Asian markets. The approval, obtained through regional distribution partner HS Biosystems, represents a key milestone in advancing biomarker-based testing for neurodegenerative diseases, particularly Alzheimer's disease.
Ultrasensitive Detection Technology
The Simoa platform delivers ultrasensitive biomarker detection in blood, serum, or plasma, with the ability to quantify proteins that are far lower than the Level of Quantification (LoQ) of traditional measurement platforms. Through its unparalleled sensitivity and multi-marker testing capability, the technology provides clinicians with minimally invasive tools that can help enhance diagnostic accuracy and improve accessibility.
"Quanterix is the only platform in the neurodegenerative space that can be used in research to discover a biomarker, power an endpoint in a clinical trial and progress to a diagnostic test," said Masoud Toloue, Chief Executive Officer at Quanterix. "Other instruments only address narrow use cases, as they are either only high-plex discovery orientated or diagnostic use only. Quanterix makes discovery to diagnostics happen by powering a critical step in between, biopharma clinical trials."
Strategic Laboratory Partnerships
Quanterix has established several new global collaborations with laboratories and patient testing centers, strengthening the infrastructure for Alzheimer's testing. Key partnerships include:
ARUP Laboratories, a leading national reference laboratory, recently launched a blood test for phosphorylated tau 217 (P-tau217) 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, described as the world's first ecosystem for memory loss with end-to-end patient support, announced an easy-to-use at-home blood biomarker collection test that can measure phosphorylated tau 217 (P-tau217), a specific marker for Alzheimer's disease pathology and mild cognitive impairment (MCI), using Quanterix's highly sensitive technology.
NSW Health Pathology, the largest public pathology service in Australia, has validated neurofilament light chain (NfL) for patient testing on the platform.
Brazilian Implementation Success
Rede D'Or, Richet Laboratory (IDOR), the largest integrated health care network in Brazil covering over 70 hospitals, was the first Brazilian institution to acquire a Simoa HD-X and implement both P-tau217 and NfL for testing. IDOR recently published research in Nature Communications on their work to reduce the underdiagnosis of Alzheimer's disease in Brazil.
"Our team works primarily on Alzheimer's Disease and dementia, so from day one, our focus has been on reporting how Simoa biomarkers perform when detecting amyloid status and cognitive decline in a local sample," said Luis Eduardo da Silva Santos, Scientist at Rede D'Or Institute for Research and Education. "IDOR was the first Brazilian institution to acquire a Simoa HD-X and we are excited to see that our work, published in Nature Communications, is now serving as the basis for the local implementation of two Simoa kits, P-tau217 ALZpath and NfL. We expect these tests to be more affordable than current alternatives and to contribute to reducing the underdiagnosis of AD in Brazil."
Early Detection Imperative
According to research cited by the company, early signs of Alzheimer's disease may begin 20 years or more before symptoms appear. The Simoa platform equips customers with advanced insights to help accelerate research and diagnosis during this crucial timeframe, allowing patients expanded access to treatments that are not available once the disease has progressed to an advanced stage.
Toloue emphasized that the ultra-sensitive Simoa technology serves as the backbone for many of the Alzheimer's tests coming to the market today, positioning the platform as a comprehensive solution spanning from biomarker discovery through clinical trials to diagnostic implementation.
