Simoa® HD-X Receives MFDS Class I IVD Import Clearance, Enabling the First Clinical Introduction of Simoa® Technology in Korea

Seoul, Republic of Korea – 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.

About Quanterix: From discovery to diagnostics, Quanterix’s ultrasensitive biomarker detection fueling breakthroughs only made possible through its unparalleled sensitivity and flexibility. The Company’s Simoa® 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 (LoQ). Its industry-leading precision instruments, digital immunoassay technology and CLIA-certified Accelerator laboratory have supported research that advances disease understanding and management in neurology, oncology, immunology, cardiology and infectious disease. Quanterix has been a trusted partner of the scientific community for nearly two decades, powering research published in more than 3,400 peer-reviewed journals. Find additional information about the Billerica, Massachusetts-based company at https://www.quanterix.com or follow us on Twitter and LinkedIn.

About Emocog: Emocog is a bio-digital healthcare company developing evidence-based digital therapeutics (DTx) and AI-driven cognitive health solutions across the full continuum of dementia care—from prevention and early detection to intervention and long-term management. The company’s name, a combination of “emotion” and “cognition,” reflects its mission to help individuals maintain healthy brain and emotional function through accessible, clinically validated digital tools. Emocog provides patients with engaging, easy-to-use therapeutic experiences embedded in daily life, while offering healthcare professionals reliable, science-based digital therapeutics and assessment instruments. Its key products include Cogscreen, an early cognitive assessment tool, and Cogthera, the first MFDS(Ministry of Food and Drug Safety of the Republic of Korea)-approved digital therapeutic in Korea for mild cognitive impairment (MCI), which has also received the CE mark in Europe. Building on these innovations, Emocog is establishing an integrated platform that connects early screening, digital therapy, prevention, and longitudinal cognitive-health management, and is actively expanding its presence in both the Korean and global markets. Emocog is headquartered in Seoul, South Korea, and operates a European subsidiary in Germany. For more information, please visit www.emocog.com/en or the Cogthera Europe website at www.cogthera.de