May 27, 2024

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FDA approved new test for early detection of Alzheimer’s disease

FDA approved new test for early detection of Alzheimer’s disease


FDA approved new test for early detection of Alzheimer’s disease. 

The U.S. Food and Drug Administration (FDA) has approved a new test for Alzheimer’s disease.

The test is the first in vitro diagnostic tool for Alzheimer’s approved for use in the United States. It is reported that the tool makes a diagnosis by measuring the level of amyloid in the spinal fluid.


FDA approved new test for early detection of Alzheimer's disease


Doctors and patients currently have few tools to diagnose Alzheimer’s disease. Aside from cognitive and psychological testing, the only way to diagnose Alzheimer’s disease is to perform a positron emission tomography (PET).

These scans measure levels of damaging amyloid and tau proteins in the brain, but they are expensive and unavailable to many patients.


The new tool, called the Lumipulse test, can effectively detect levels of amyloid aggregation in the brain by looking for two specific amyloid proteins in the cerebrospinal fluid.


A clinical trial testing Lumipulse on PET scans found it was 97 percent accurate in picking out patients with brain amyloid buildup.


William Hu, the researcher who worked on the development of the test, said: “If we are to make real progress against this terrible disease, the development of accurate AD (Alzheimer’s disease) using biomarkers found in cerebrospinal fluid or other body fluids ) testing is a requirement. The importance of early diagnosis for AD is widely recognized, but until now, there has not been an approved biomarker test available to clinicians and patients.”


The Lumipulse test is certainly not an easy test. The procedure for collecting a spinal fluid sample is not as simple as a blood test. The new test, however, will make amyloid measurements greatly accessible to more patients across the United States.


A statement from the FDA noted that the test is only available for adults over the age of 55 who are being evaluated by a doctor for Alzheimer’s disease.

The test is not intended to be used as a general screening or diagnostic tool, but to help doctors rule out early-onset Alzheimer’s disease in patients with neurological problems.


“The advent of an in vitro diagnostic test has the potential to eliminate the need for time-consuming and expensive PET scans for individuals and families concerned about the possibility of Alzheimer’s diagnosis,” said Jeff Shuren, FDA’s Director of Devices and Radiological Health. That’s good news. With the Lumipulse test, there is a new option, usually done the same day, that can give doctors the same information about the brain’s amyloid status — and without the risk of radiation — to help determine Whether the patient’s cognitive impairment is caused by Alzheimer’s disease.”



FDA approved new test for early detection of Alzheimer’s disease

(source:internet, reference only)

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