FDA Greenlights First In-Vitro Alzheimer’s Diagnostic

The U.S. Food and Drug Administration (FDA) authorized marketing for the first in-vitro diagnostic test for early detection of amyloid plaques associated with Alzheimer’s disease, eliminating the need for time-consuming and expensive PET scans, with test results available on the same day. 

Lumipulse G β-Amyloid Ratio (1-42/1-40) test by Fujirebio Diagnostics taps the unmet demand for a reliable and safe test that can accurately identify patients with amyloid plaques associated with Alzheimer’s disease. Previously, doctors relied on positron emission tomography (PET) scans to detect amyloid plaques in patient’s brain to diagnose Alzheimer’s disease before symptoms occur.

Related Article: Biogen Halts Aduhelm’s Second EU Marketing Application

Detecting Amyloid Plaques from Cerebral Spinal Fluid

Alzheimer’s disease (AD) is the most common neurodegenerative disease with more than 40 million cases reported worldwide, characterized by the aggregation of the beta-amyloid proteins in the Alzheimer’s brain, abnormal levels of this naturally occurring protein clump together to form plaques that disrupt brain cell function.

In the race to detect the disease earlier and begin treatments sooner, this in-vitro assay measures amyloid plaque concentration in the cerebral spinal fluid (CSF), serving as another more accessible diagnosis tool. The FDA reports that it evaluated the safety and efficacy of the test in a clinical study of 292 CSF samples from the Alzheimer’s Disease Neuroimaging Initiative sample bank.

“With the Lumipulse test, there is a new option that can typically be completed the same day and can give doctors the same information regarding brain amyloid status, without the radiation risk, to help determine if a patient’s cognitive impairment is due to Alzheimer’s disease,” said Jeff Shuren, director of the FDA’s Center for Devices and Radiological Health.

This decision follows around one year after FDA authorized Biogen’s Alzheimer’s disease therapy Aduhelm (aducanumab) based on a reduction in brain amyloid plaque. 

Author

Fujie Tham