The US Food and Drug Administration (FDA) has approved the Lumipulse G blood test, developed by Fujirebio Diagnostics, as a diagnostic tool for Alzheimer’s disease. The test measures two proteins in the bloodstream associated with amyloid plaque buildups in the brain. This is the first FDA-approved blood-based test for Alzheimer’s diagnosis.
The approval could reduce the need for invasive procedures like spinal taps or expensive PET scans. Nearly 7 million Americans live with Alzheimer’s, and the number is projected to rise to nearly 13 million. The FDA says this new test makes it easier and potentially more accessible for US patients to receive an earlier diagnosis.
Clinical trials of the Lumipulse blood test showed high accuracy rates, with 91.7% of people with positive results confirmed correct and 97.3% of negative findings also accurate. The test is intended for adults aged 55 and older who show signs and symptoms of cognitive decline. It can aid in identifying Alzheimer’s patients from those with other types of dementia.
Fujirebio has partnered with Japanese drugmaker Eisai to study and promote blood-based biomarkers for neurodegenerative diseases. This approval marks a significant step forward in Alzheimer’s research, where innovation, science, and technology come together to develop more accessible and affordable diagnostic tools.
Source: https://www.fiercebiotech.com/medtech/fda-clears-fujirebios-blood-test-diagnosing-alzheimers-disease