Digital Healthcare corporations Emocog said on the 10th that it signed an exclusive domestic supply contract with Lucent Diagnostics, the clinical diagnostics brand of U.S. biotech corporations Quanterix, for analyzers based on the ultra-high-sensitivity protein analysis technology "Simoa" and blood-based in vitro diagnostic (IVD) reagents.
It is the first time the Simoa platform has been introduced in Korea as a formal in vitro diagnostic medical device (IVD) system rather than for research use only (RUO). Emocog filed an import notification with the Ministery of Food and Drug Safety in Oct. for the "Simoa HD-X" analyzer as a Class 1 in vitro diagnostic medical device.
Simoa is an ultra-high-sensitivity digital immunoassay technology that can quantify proteins at the single-molecule level in blood, serum, and other samples. It can detect biomarkers at much lower concentrations than conventional testing methods. The HD-X device is widely used in research and clinical practice for neurodegenerative diseases such as Alzheimer's.
Emocog is preparing domestic clinical trials and approvals for major Simoa diagnostic reagents, including pTau217, a core blood biomarker (biological indicator) for Alzheimer's. The company said that once the reagents are approved, medical institutions will be able to offer a diagnostic service that provides an early assessment of Alzheimer's risk with a single blood draw.
The company built a "full-cycle dementia Digital Healthcare ecosystem" through this partnership by consolidation a digital cognitive assessment solution (CogScreen), a mobile-based digital therapeutic device for mild cognitive impairment (CogThera), and a blood-based Alzheimer's screening platform (Simoa).
Lee Jun-young, CEO of Emocog, said, "It is significant in that it expands ultra-high-sensitivity blood biomarker analysis, which has been research-focused, into the medical system," and added, "Once the reagents are approved, we will complete an integrated ecosystem by consolidation digital assessment, cognitive intervention, and blood-based diagnostics, contributing to strengthening dementia response at the national level."
Ben Meadows, chief commercial officer (CCO) of Quanterix, said, "The introduction of Simoa as a formal IVD system in Korea is an important advance in our global diagnostics strategy," adding, "Together with Emocog, we will set a new standard for ultra-high-sensitivity blood-based early diagnosis of dementia." Emocog plans to pursue expansion of the domestic IVD market, adoption by large medical institutions, establishment of insurance and care pathways, and cooperation on an Asia diagnostics network.