BREDIS Healthcare Designated as 'Good Clinical Laboratory Practice (GCLP)' Institution by the Ministry of Food and Drug Safety (MFDS)

BREDIS Healthcare (Co-CEOs Hyundoo Hwang and Jina Kim) announced on the 23rd that it has been designated as a Good Clinical Laboratory Practice (GCLP) institution by the Ministry of Food and Drug Safety (MFDS). A GCLP-designated institution is authorized to analyze samples obtained during clinical trials, with designation granted by the MFDS Commissioner following a rigorous inspection process based on the Pharmaceutical Affairs Act and related regulations. To receive this designation, an institution must meet strict requirements covering specialized personnel, facilities and equipment maintenance, handling facilities for test and control substances, and dedicated testing areas. BREDIS Healthcare holds Digital ELISA (digital immunoassay) technology capable of accurately detecting disease biomarkers present in bodily fluids at concentrations as low as the femtogram (fg/mL) level. Since its founding last year, the company has provided blood and cerebrospinal fluid biomarker analysis services to more than 10 leading general hospitals in Korea and abroad, as well as institutions such as the National Institute of Health under the Korea Disease Control and Prevention Agency. Using this technology, key biomarkers related to Alzheimer's disease can be detected in blood, enabling early diagnosis of the disease and even early warning of dementia risk. BREDIS Healthcare is capable of performing plasma pTau217 analysis, which can predict brain amyloid PET results — essential for Alzheimer's diagnosis — with 96% accuracy. "This GCLP designation is significant in that it makes clinical trials capable of analyzing ultra-low-concentration biomarkers at the fg/mL level possible in Korea for the first time," said Hyundoo Hwang, CEO of BREDIS Healthcare, on the significance of the designation. "Using blood tests, we can dramatically reduce the cost of the large-scale clinical trials essential to developing treatments for Alzheimer's-related dementia." The global medical community is focused on developing treatments for dementia — one of the major challenges of an aging society — and in particular for Alzheimer's disease, which accounts for 75% of all dementia cases. Blood biomarker analysis technology is regarded as a key technology capable of significantly reducing the cost of dementia diagnosis in this process. Founded in February of last year, BREDIS Healthcare is developing technology that uses blood-based diagnostics to detect cognitive impairment at its earliest, or even pre-symptomatic, stages, enabling disease prevention and early treatment. Recognized for the excellence of its technology, the company has provided blood biomarker analysis services to numerous hospitals and research institutions in Korea and abroad since shortly after its founding.