Quanterix Corporation (NASDAQ: QTRX), a U.S.-based biotechnology company specializing in ultrasensitive biomarker detection, and its clinical diagnostics brand Lucent Diagnostics, together with Emocog Inc. (Co-CEOs Jun-Young Lee and Yoo-Hun Noh), a digital healthcare company based in Seoul, South Korea, today announced that the companies have entered into an exclusive distribution agreement for the Korean market covering the Simoa® (Single Molecule Array) technology platform — including the ultra-sensitive HD-X immunoassay analyzer and blood-based Alzheimer’s biomarker reagents.  

This agreement 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 (RUO) instrument, representing an important milestone in the development of Korea’s blood-based Alzheimer’s diagnostics ecosystem.  

In late October 2025, Emocog obtained Class I In Vitro Diagnostic (IVD) Medical Device import clearance from the Ministry of Food and Drug Safety (MFDS) for the Simoa® HD-X analyzer, establishing the regulatory foundation required to introduce IVD-based blood testing into the Korean healthcare system.  

The Simoa® 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.  

Emocog is now preparing Korean clinical and IVD regulatory submissions for Quanterix’s pTau217 assay and other Simoa®-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.  

Through this partnership, Emocog now connects its entire Full-Cycle Digital Dementia Healthcare Ecosystem, integrating:  

• Cogscreen, a web-based digital early cognitive assessment tool  

• Cogthera®, a mobile-based MFDS-approved digital therapeutic for MCI  

• Simoa®, a blood-based ultra-sensitive diagnostic platform  

Together, these solutions establish the first fully integrated digital-biological dementia care ecosystem in Korea.  

“The introduction of the Simoa® 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.”  

“Korea’s adoption of the Simoa® platform as a formally approved IVD device represents a major advancement in Quanterix’s global diagnostic strategy,” said Ben Meadows, Chief Commercial Officer, Quanterix Corporation. “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.”  

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.