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What is the Lumipulse test for Alzheimer’s disease?
In May, the U.S. Food and Drug Administration approved Lumipulse (GB-amyloid ratio) [1-42/1-40]) tested to Fujirebio Diagnostics, Inc. of Malvern, PA. Granted Breakthrough Device Designation by the FDA, the test is the first FDA-authorized in vitro diagnostic test in the U.S. to help evaluate B-amyloid pathology in patients with Alzheimer’s disease and other causes of cognitive decline .
The presence of B-amyloid plaques in the brain is a hallmark of Alzheimer’s disease and is thought to contribute to the loss of cognitive function. Accurate assessment of this amyloid pathology is difficult, and often clinicians rely primarily on cognitive assessments, which include cognitive screening tests. However, according to a study by Julie A. Schneider, Z. Leurgans, and SE Bennet DA, respectively, in Ann Neurol (2009), in the early stages of the disease, the diagnosis of Alzheimer’s disease relies primarily on cognitive tests. It is incorrect in about 50% to 60% of patients.
The Lumipulse test provides an alternative to current protocols for determining amyloid pathology, such as amyloid positron emission tomography (PET) brain imaging, which can be expensive, subjective, time-consuming, and many Americans Not usually available, and not usually covered by health insurance for some people. Designed for adults 55 and older with cognitive impairment who are being evaluated for Alzheimer’s disease and other causes of cognitive decline, the test is accurate and minimally invasive to detect amyloid plaques early in the disease Formation.
“With the Lumipulse test, there is a new option that can often be done on the same day and can provide physicians with the same information about brain and amyloid status without the risk of radiation to help determine whether a patient’s cognitive impairment is caused by AL caused by Zheimer’s disease,” Jeff Suren, MD, JD, director of the FDA’s Center for Devices and Radiological Health, said in the FDA’s press release.
For individuals experiencing cognitive decline, obtaining an early and accurate diagnosis is important for planning and early treatment selection. While amyloid plaques can occur in other diseases, being able to detect the presence of plaques, along with other assessments, can help physicians identify individual symptoms and possible causes of findings.
A positive Lumipulse test result is consistent with the presence of amyloid plaques. Negative test results reduce the likelihood that an individual’s cognitive impairment is caused by Alzheimer’s disease, allowing doctors to look for other causes of cognitive decline and dementia. This test is not intended to be used as a screening or stand-alone diagnostic analysis, and positive test results may also be seen in individuals with other types of neurological disorders.
Risks associated with the Lumipulse test include the possibility of false positive and false negative test results, which is why it is not an independent test and requires other clinical evaluations and additional testing to determine treatment options. Lumipulse testing is performed in clinical laboratories nationwide with Fujirebio’s Lumipulse G1200 instrument system.
For more information, please visit the website, www.fujirebio.com/en-us.
Questions about Alzheimer’s disease or related conditions can be sent to Dana Territo, author of What My Grandchildren Teach Me About Alzheimer’s Disease at thememorywhisperer@gmail.com.
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