FDA Permits Marketing of New Diagnostic Test for Alzheimers Disease

The US Food and Drug Administration has permitted marketing for the first in vitro diagnostic test for early detection of amyloid plaques associated with Alzheimers disease, which the. National Institutes of Health state affects more than 6 million Americans.

The Lumipulse G β-Amyloid Ratio (1-42/1-40) test will be intended for adult patients 55 years and older who presenting with cognitive impairments who are being evaluated for the disease and other causes of cognitive decline.

Due to the progressive nature of Alzheimers disease, accurate diagnosis is critical in helping patients and caregivers with early treatment options. Currently, there is an unmet need for safe and reliable tests that can identify amyloid plaques related to the brain disorder.

Prior to this authorization by the FDA, doctors have utilized costly positron emission tomography (PET) scans to detect amyloid plaques in patients. The Lumipulse test will be used to measure the ratio of β-amyloid 1-42 and β-amyloid 1-40 (plaque forming proteins) concentrations found in human cerebral spinal fluid (CSF), which can help in determining whether a patient is likely to have amyloid plaques.

“The availability of an in vitro diagnostic test that can potentially eliminate the need for time-consuming and expensive PET scans is great news for individuals and families concerned with the possibility of an Alzheimer’s disease diagnosis,” said Jeff Shuren, MD, director of the FDA’s Center for Devices and Radiological Health. “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.”

A positive Lumipulse G β-amyloid Ratio (1-42/1-40) test result will be consistent with the presence of amyloid plaques, while a negative result will indicate a negative amyloid PET scan result.

The FDA allowed for marketing of the test after evaluating the safety and effectiveness of this test in a clinical study of 292 CSF samples from the Alzheimer’s Disease Neuroimaging Initiative sample bank.

The samples were tested by the Lumipulse G β-amyloid Ratio (1-42/1-40) before being compared with amyloid PET scan results. Among these sample participants, 97% of individuals with Lumipulse G β-amyloid Ratio (1-42/1-40) positive results had the presence of amyloid plaques by PET scan and 84% of individuals with negative results had a negative amyloid PET scan.

Previously, the Lumipulse G β-amyloid Ratio (1-42/1-40) was granted Breakthrough Device designation by the FDA. Marketing of the Lumipulse G ß-Amyloid Ratio (1-42/1-40) was permitted to Fujirebio Diagnostics, Inc.