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FDA Approves New Test for Early Detection, Diagnosis of Alzheimer Disease
The US Food and Drug Administration (FDA) approved the first in vitro diagnostic test for the early detection of amyloid plaques, one of the pathological hallmarks associated with Alzheimer disease. The Lumipulse G b-Amyloid Ratio (1-42/1-40) test is designed for use in patients 55 and older exhibiting cognitive impairment and undergoing evaluation for Alzheimer and neurodegenerative disease.
“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 disease diagnosis,” said Jeff Shuren, MD, JD, 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 disease,” Shuren added.
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The Lumipulse test measures the ratio of b-amyloid 1-42 and b-amyloid 1-40 concentrations present in patients’ cerebral spinal fluid (CSF). The test results, in conjunction with other clinical information, can help doctors determine which disease is the cause for the patient’s symptoms. Whether Alzheimer or not, such methods increase the chance of an early and accurate diagnosis that enables immediate intervention to slow progressive degenerative diseases.
The FDA notes that the great risk associated with use of the test is the possibility of false-positive and false-negative test results. In its own clinical study of 292 CSF samples, 97% of those with Lumipulse G b-Amyloid Ratio (1-42/1-40)–positive results had the presence of amyloid plaques confirmed by positron emission tomography (PET) scan; 84% of those with Lumipulse G b-Amyloid Ratio (1-42/1-40)–negative results had the absence of amyloid plaques confirmed by PET scan.
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