Bredis Healthcare Secures Export Approval for Blood-Based Alzheimer’s Disease Diagnostic Device

Bredis Healthcare (CEO Hyundoo Hwang) has laid the groundwork for entering overseas markets with an in vitro diagnostic medical device that measures Alzheimer’s disease-related biomarkers using blood samples.

Bredis Healthcare announced on the 18th that it has obtained export approval from the Ministry of Food and Drug Safety (MFDS) for the in vitro diagnostic medical device ‘BREDIS DIA P-tau217 S,’ which measures P-tau217 (phosphorylated tau 217) in blood.

The product measures the concentration of P-tau217 in EDTA plasma samples from patients with mild cognitive impairment or mild dementia. The measurement results are intended to help predict the likelihood of amyloid PET positivity and support decisions on whether PET imaging is necessary.

The clinical performance of the product was evaluated through an exploratory clinical trial. In an exploratory clinical trial conducted using actual clinical specimens in collaboration with the research team led by Professor Sung-Ho Ko of Hanyang University Guri Hospital, BREDIS DIA P-tau217 S demonstrated a clinical sensitivity of 94.4% and a clinical specificity of 94.1%.

Cerebrospinal fluid (CSF) analysis and positron emission tomography (PET) have traditionally been used to assess key biomarkers associated with Alzheimer’s disease. As these methods may involve burdens related to specimen collection or imaging procedures during the diagnostic process, interest in blood-based biomarkers has been growing.

Blood tests are relatively accessible because samples can be obtained through a blood draw. In particular, P-tau217, one of the blood-based biomarkers associated with Alzheimer’s disease, has been the subject of ongoing research as a biomarker for assessing pathological changes associated with the disease.

BREDIS DIA P-tau217 S was developed to measure low concentrations of P-tau217 present in plasma at the pg/mL level. According to Bredis Healthcare, the product has secured the potential to be utilized in Alzheimer’s disease-related assessments using blood samples.

Based on the export approval, Bredis Healthcare plans to pursue commercialization in overseas markets. The company also plans to expand partnerships with overseas companies and institutions and strengthen its global business competitiveness in the field of blood-based Alzheimer’s disease diagnostics.

Hyundoo Hwang, CEO of Bredis Healthcare, said, “Obtaining export approval marks an important milestone that demonstrates Bredis Healthcare’s technological capabilities in the field of blood-based Alzheimer’s disease diagnostics. Based on the product performance demonstrated through the exploratory clinical trial, we will continue to build clinical evidence and accelerate our entry into global markets to strengthen our competitiveness.”