US FDA Approves First Blood Test to Diagnose Alzheimer Disease

The United States Food and Drug Administration granted full approval to Lumipulse, a blood-based biomarker test developed by Fujirebio that can accurately diagnose Alzheimer disease by detecting abnormal ratios of amyloid-beta 40 and 42 proteins in blood plasma, replacing the need for expensive PET brain scans or invasive cerebrospinal fluid collection in most cases. Clinical validation studies showed 91% concordance with PET imaging results across a diverse dataset of 1,200 patients. The test costs approximately $200 compared to $5,000 for PET scans, dramatically expanding access to early diagnosis especially in low-resource settings. India Drug Controller General is reviewing an application for Lumipulse approval, with Apollo Diagnostics and SRL Diagnostics already planning nationwide rollout subject to regulatory clearance. Neurologists estimate early diagnosis enabled by Lumipulse could allow interventions that delay dementia onset by up to seven years.