Alzheimer's disease may soon be diagnosable through a simple blood draw at local clinics. The latest FDA-approved blood-based testing method is expected to arrive in Korea as early as this year, potentially triggering explosive growth in a dementia blood diagnosis market that has been limited to supplementary screening at select examination centers.
According to medical industry sources on June 4, Roche Diagnostics Korea applied to the Ministry of Food and Drug Safety in the second half of last year for approval of its 'Elecsys pTau181' analytical test.
Elecsys pTau181 measures pTau181, a type of tau protein with attached phosphate groups, in blood plasma. Tau protein is identified as a core cause of Alzheimer's disease, which accounts for approximately 60-70% of all dementia cases. The test achieved a 97.9% negative predictive value in clinical trials involving 312 participants, earning FDA approval in October last year. This means it can identify patients with cognitive decline who do not have Alzheimer's disease with approximately 98% accuracy.
Korea is not entirely new to dementia blood diagnostics. PeopleBio pioneered the market in 2018 by successfully commercializing 'Alzsure,' the world's first Alzheimer's blood diagnostic kit. Alzsure assesses Alzheimer's risk by measuring the degree of oligomerization of amyloid-beta proteins in plasma, specializing in detecting early warning signs when toxic substances begin accumulating in the brain. While currently used for screening purposes at major health examination centers including KMI Korea Medical Institute and Hanaro Medical Foundation, amyloid positron emission tomography (PET) scans still overwhelmingly dominate clinical practice. PET scans cost around 1 million won per session and carry radiation exposure concerns, yet blood-based dementia diagnosis remains an unfamiliar concept. Cerebrospinal fluid testing is less expensive but has low accessibility due to patient reluctance toward invasive procedures and limited availability at qualified institutions.
The medical community expects the introduction of Elecsys pTau181 to catalyze growth in the dementia blood diagnosis market. Alzsure would serve as an "early warning system" for Alzheimer's risk, while Elecsys would function as a "precision radar" for actual disease detection, creating significant synergy. Most importantly, local clinics would be able to easily screen for Alzheimer's disease, facilitating earlier treatment interventions.
In the United States, two Alzheimer's blood diagnostic devices received FDA approval last year: Roche's Elecsys pTau181 and 'Lumipulse,' developed by Japanese biotech company Fujirebio. Lumipulse determines Alzheimer's probability by measuring the ratio of phosphorylated tau 217 (pTau217) to amyloid-beta 42 protein in blood.
The growing attention to blood diagnostic technology reflects the surge in dementia populations and the emergence of disease-modifying treatments (DMTs). According to the World Health Organization, 57 million people worldwide had dementia as of 2021, a figure projected to triple by 2050. 'Leqembi,' introduced in Korea in December 2024, costs approximately 30 million won annually in medication alone but has clear limitations—it only slows cognitive decline without improving memory itself. Treatment must begin early for meaningful effectiveness.
"In early-stage Alzheimer's disease, where cognitive decline symptoms are not yet prominent, biological biomarkers prove highly useful," said Lee Sang-kuk, professor of laboratory medicine at Severance Hospital. "The academic community has already reached consensus that blood-based biomarker testing will play a central role in early Alzheimer's diagnosis, surpassing PET scans."
He added, "Once blood tests are covered by insurance, primary care facilities will be better equipped to screen cognitive decline patients more accurately and efficiently. Given the exponential increase in dementia patients, swift approval and national health insurance coverage are essential."