The US Food and Drug Administration (FDA) has approved Fujirebio Diagnostics’ Alzheimer’s disease (AD) blood test to help detect the neurodegenerative disease earlier.
The decision makes the diagnostic device, Lumipulse G pTau217/ß-Amyloid 1-42 Plasma Ratio, the first AD blood test to be cleared by the regulator.
The device has been specifically authorised for the early detection of amyloid plaques associated with AD in adults aged 55 years and older who are exhibiting signs and symptoms of the disease.
AD is the most common form of dementia, affecting approximately seven million people in the US. The disease progressively destroys memory and thinking skills and, eventually, the ability to carry out simple tasks.
Amyloid plaques in the brain are a hallmark sign of AD and can be detected using amyloid positron emission tomography (PET) brain scans, sometimes years before clinical symptoms develop. However, these are costly, time-consuming and expose patients to radiation.
Tests using cerebrospinal fluid (CSF) samples, which are collected through an invasive lumbar puncture, can also aid in diagnosis.
Only requiring a simple blood draw, Fujirebio’s test is designed to measures two proteins found in human plasma and calculates the ratio between them, which correlates to the presence or absence of amyloid plaques in the brain.
The FDA’s decision was supported by results from a clinical trial of 499 individual plasma samples from adults who were cognitively impaired.
In the study, 91.7% of patients who tested positive with Fujirebio’s test had the presence of amyloid plaques by PET scan or CSF test result, and 97.3 % of those who tested negative had a negative amyloid PET scan or CSF test result.
Fujirebio’s president and chief executive officer, Monte Wiltse, said: “The lack of effective, accessible and minimally invasive diagnostics for AD contributes to its late diagnosis and inadequate treatment.
“The Lumipulse G pTau 217/ β-Amyloid 1-42 Plasma Ratio test will go a long way to assist physicians and patients to obtain an AD diagnosis in early stages of the disease, when interventions are more effective.”