The following is an abbreviated version of the original release.
The U.S. Food and Drug Administration is permitting marketing for the first in vitro diagnostic test for early detection of amyloid plaques associated with Alzheimer’s disease. The Lumipulse G β-Amyloid Ratio (1-42/1-40) test is intended to be used in adult patients, aged 55 years and older, presenting with cognitive impairment who are being evaluated for Alzheimer’s disease and other causes of cognitive decline.
The Lumipulse test is intended to measure the ratio of β-amyloid 1-42 and β-amyloid 1-40 (specific proteins that can accumulate and form plaques) concentrations found in human cerebral spinal fluid (CSF), which can help physicians determine whether a patient is likely to have amyloid plaques, a hallmark sign of Alzheimer’s disease. Results must be interpreted in conjunction with other patient clinical information.
A positive Lumipulse G β-amyloid Ratio (1-42/1-40) test result is consistent with the presence of amyloid plaques, similar to what would be seen in a PET scan. A negative result is consistent with a negative amyloid PET scan result. A negative test result reduces the likelihood that a patient’s cognitive impairment is due to Alzheimer’s disease, enabling physicians to pursue other causes of cognitive decline and dementia. The test is not intended as a screening or standalone diagnostic assay. There is also the possibility that a positive test result could be seen in patients with other types of neurologic conditions, as well as in older cognitively healthy people, which underscores the importance of using this test in conjunction with other clinical evaluations.
The FDA evaluated 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) and compared with amyloid PET scan results. In this clinical study, 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.
Importantly, the Lumipulse G β-amyloid Ratio (1-42/1-40) is not a standalone test and other clinical evaluations or additional tests should be used for determining treatment options.
The FDA reviewed the device through the De Novo premarket review pathway, a regulatory pathway for low- to moderate-risk devices of a new type. This action creates a new regulatory classification, which means that subsequent devices of the same type with the same intended use may go through FDA’s 510(k) premarket process, whereby devices can obtain marketing authorization by demonstrating substantial equivalence to a predicate device.
The Lumipulse G β-amyloid Ratio (1-42/1-40) was granted Breakthrough Device designation, a process designed to expedite the development and review of devices that may provide for more effective treatment or diagnosis of life-threatening or irreversibly debilitating diseases or conditions.
The FDA has permitted marketing of the Lumipulse G ß-Amyloid Ratio (1-42/1-40) to Fujirebio Diagnostics.