Quanterix and Emocog Partner to Bring Ultra-Sensitive Alzheimer's Blood Testing to Korea
核心洞察
Quanterix Corporation (搜索) and Emocog Inc. (搜索) have signed an exclusive distribution agreement to introduce the Simoa (搜索) ultra-sensitive immunoassay platform to Korea as an authorized IVD device.
Emocog obtained Class I IVD Medical Device import clearance from Korea's Ministry of Food and Drug Safety for the Simoa (搜索) HD-X analyzer in late October 2025.
The partnership will integrate blood-based Alzheimer's diagnostics with Emocog's digital assessment and therapeutic tools to create Korea's first fully integrated digital-biological dementia care ecosystem.
Quanterix Corporation (搜索) and its clinical diagnostics brand Lucent Diagnostics (搜索) have entered into an exclusive distribution agreement with Seoul-based digital healthcare company Emocog Inc. (搜索) to bring the Simoa (搜索) (Single Molecule Array) technology platform to the Korean market. The partnership marks the first introduction of the Simoa platform into Korea as a formally authorized In Vitro Diagnostic (IVD) device rather than a research-use-only instrument.
Regulatory Milestone Achieved
In late October 2025, Emocog obtained Class I In Vitro Diagnostic Medical Device import clearance from Korea's Ministry of Food and Drug Safety for the Simoa (搜索) HD-X analyzer. This regulatory approval establishes the foundation required to introduce IVD-based blood testing into the Korean healthcare system, representing an important milestone in the development of Korea's blood-based Alzheimer's diagnostics ecosystem.
Ultra-Sensitive Detection Technology
The Simoa (搜索) platform is an ultra-sensitive digital immunoassay technology capable of detecting and quantifying proteins at the single-molecule level in blood, serum, or plasma, with sensitivity far beyond traditional assay limits. The HD-X analyzer, Quanterix's flagship model, is widely used by leading pharmaceutical companies, top-tier hospitals, and neuroscience research centers worldwide for Alzheimer's disease and other neurodegenerative biomarker applications.
Advancing Alzheimer's Biomarker Testing
Emocog is now preparing Korean clinical and IVD regulatory submissions for Quanterix's pTau217 (搜索) assay and other Simoa (搜索)-based Alzheimer's biomarkers. pTau217 is globally regarded as one of the most accurate and rapidly standardizing biomarkers for early Alzheimer's detection. Once regulatory approval is secured, Emocog plans to introduce a clinical blood-based diagnostic service that can assess Alzheimer's risk from a single blood draw.
Integrated Digital Healthcare Ecosystem
Through this partnership, Emocog connects its entire Full-Cycle Digital Dementia Healthcare Ecosystem, integrating three key components:
- Cogscreen: A web-based digital early cognitive assessment tool
- Cogthera: A mobile-based MFDS-approved digital therapeutic for mild cognitive impairment
- Simoa: A blood-based ultra-sensitive diagnostic platform
Together, these solutions establish the first fully integrated digital-biological dementia care ecosystem in Korea.
Industry Leadership Perspectives
"The introduction of the Simoa (搜索) platform into Korea creates a foundation for expanding ultra-sensitive blood biomarker analysis from research into real-world clinical settings," said Jun-young Lee, CEO of Emocog. "Once biomarker assay approvals are completed, Emocog will establish an integrated cognitive-health ecosystem connecting digital assessment, digital therapy, and blood-based diagnostics — enhancing Korea's national capacity for early dementia detection and management."
Ben Meadows, chief commercial officer at Quanterix Corporation (搜索), emphasized the strategic significance of the partnership: "Korea's adoption of the Simoa (搜索) platform as a formally approved IVD device represents a major advancement in Quanterix's global diagnostic strategy. Together with Emocog — a leader in digital and AI-driven dementia innovation — we will work to establish a new standard for ultra-sensitive, blood-based Alzheimer's diagnostics in the Korean healthcare system."
Future Development Plans
Emocog will continue collaborating with Quanterix and Lucent to advance nationwide IVD adoption, expand hospital-level deployment, build reimbursement pathways, and strengthen Korea's position as an Asia-Pacific diagnostic hub. The Simoa (搜索) technology has delivered the gold standard for earlier biomarker detection in blood, serum or plasma, with the ability to quantify proteins that are far lower than the Level of Quantification.