BREDIS Healthcare Registers 'BREDIS DIA Reader' as Class 1 In Vitro Diagnostic Medical Device with MFDS

BREDIS Healthcare announced that it has developed the "BREDIS DIA Reader," a blood test-based medical device built on Digital Immunoassay technology, and has completed registration of the device as a Class 1 in vitro diagnostic medical device with the Ministry of Food and Drug Safety (MFDS). The BREDIS DIA Reader is the world's first commercialization of digital immunoassay technology in a medical device, drawing attention for its potential to position Korean bio-healthcare technology as a global market leader. BREDIS Healthcare's proprietary, patented digital immunoassay technology offers several thousand times the sensitivity of conventional immunoassay methods (ELISA), enabling the quantitative measurement of proteins present in the body at concentrations as low as the femtogram-per-milliliter (fg/mL) level. Once medical devices such as the BREDIS DIA Reader, built on this ultrasensitive biomarker detection technology, are introduced into clinical settings, they are expected to open new possibilities in the early diagnosis and precision treatment of neurodegenerative diseases such as Alzheimer's disease, as well as cardiovascular disease and cancer. Building on the newly registered BREDIS DIA Reader, BREDIS Healthcare plans to move forward with commercializing digital immunoassay diagnostic kits capable of measuring key biomarkers for Alzheimer's disease and other neurodegenerative diseases, including phosphorylated tau at threonine 217 (p-tau217), neurofilament light chain (NfL), and glial fibrillary acidic protein (GFAP). The company aims to establish mass production capabilities and pursue global market entry through FDA approval. "This product launch marks the starting point in demonstrating the global competitiveness of digital immunoassay technology developed with Korean expertise," said Hyundoo Hwang, CEO of BREDIS Healthcare. "BREDIS Healthcare will continue to contribute to the early detection and precision treatment of intractable diseases, including neurodegenerative brain diseases, through innovative diagnostic technology." BREDIS Healthcare has also been designated as a GCLP (Good Clinical Laboratory Practice) institution by the MFDS, and continues to provide clinical trial sample analysis services using its digital immunoassay technology — contributing to accelerating progress in related industries, including the development of Alzheimer's disease treatments.