What is the Lumipulse Alzheimer’s test?
In May, the US Food and Drug Administration approved the marketing of Lumipulse (G B-amyloid ratio [1-42/1-40]) test of Fujirebio Diagnostics, Inc. of Malvern, Pennsylvania. The test, which received breakthrough device designation from the FDA, is the first FDA-cleared in vitro diagnostic test in the United States to help assess B-amyloid pathology in patients being evaluated for Alzheimer’s disease and other causes of cognitive decline.
The presence of B-amyloid plaques in the brain, characteristic of Alzheimer’s disease, are thought to be contributing factors to the loss of cognitive function. Accurate assessment of this amyloid pathology is difficult, and clinicians typically rely primarily on cognitive assessments, which include a cognitive screening test. Yet, according to a study in Ann Neurol (2009) by Julie A. Schneider, Z. Leurgans, and SE Bennet DA, respectively, in the early stages of the disease, Alzheimer’s diagnoses relying primarily on cognitive tests have been shown to be incorrect in approximately 50% to 60% of patients.
The Lumipulse test offers an alternative to the current protocol for determining amyloid pathology, such as amyloid positron emission tomography (PET) brain imaging, which can be expensive, subjective, time-consuming, often unavailable to many Americans, and often not covered by some health insurances. The test, designed for use in adults age 55 and older with cognitive impairment who are being evaluated for Alzheimer’s disease and other causes of cognitive decline, is accurate and minimally invasive and can detect the formation of amyloid plaques early in the disease.
“With the Lumipulse test, there is a new option that can usually be completed the same day and can give doctors the same information about brain and amyloid status, without the risk of radiation, to determine whether a patient’s cognitive impairment is due to Alzheimer’s disease.” , noted Jeff Suren, MD, JD, director of the FDA’s Center for Devices and Radiological Health, in an FDA news release.
For the individual experiencing cognitive decline, obtaining an early and accurate diagnosis is important for planning and early treatment options. While amyloid plaques can occur in other diseases, being able to detect the presence of plaque, along with other assessments, helps doctors determine the likely cause of individual symptoms and findings.
A positive Lumipulse test result is consistent with the presence of amyloid plaques. A negative test result makes it less likely that an individual’s cognitive impairment is due to Alzheimer’s disease, allowing doctors to pursue other causes of cognitive decline and dementia. The test is not intended to be used as a screening or stand-alone diagnostic test, and a positive test result may also be seen in individuals with other types of neurological conditions.
Risks associated with the Lumipulse test include the possibility of false positive and false negative test results, therefore it is not a stand-alone test and other clinical evaluations and additional tests should be done to determine treatment options. The Lumipulse test is performed in clinical laboratories across the country equipped with Fujirebio’s Lumipulse G1200 instrument system.
For more information, visit www.fujirebio.com/en-us.
Questions about Alzheimer’s or related disorders can be sent to Dana Territo, author of What My Grandchildren Taught Me About Alzheimer’s, at [email protected]