Express Detects Alzheimer's-Related Amyloid Deposits Early, FDA Approves First In Vitro Diagnostic Test Today

▎WuXi AppTec Content Team Editor The U.
S.
Food and Drug Administration announced today that it has approved the first in vitro diagnostic test for the early detection of amyloid plaques associated with Alzheimer's disease
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The Lumipulse G beta amyloid ratio (1-42/1-40) test developed by Fujirebio Diagnostics is intended for use in adult patients over the age of 55 who present with cognitive impairment and are being evaluated for Alzheimer's disease or other conditions that cause cognitive decline
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Alzheimer's disease is the most common neurodegenerative disease of the elderly
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Early and accurate diagnosis is important to help patients and caregivers plan early treatment options
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There is still a lack of safe and reliable tests to detect amyloid plaques in the brains of patients
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Before today's approval, doctors used positron emission tomography (PET) to visualize and find amyloid plaques in patients' brains
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However, this option is not widely used by the majority of patients for a number of reasons
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The Lumipulse test is designed to measure the ratio of beta-amyloid 1-42 to beta-amyloid 1-40 concentrations in a patient's cerebrospinal fluid (CSF).
One of the hallmark features of Haimer's disease, test results must be comprehensively evaluated and interpreted along with other patient clinical information
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This test has been granted breakthrough medical device designation by the FDA
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Image credit: 123RFFDA's assessment of the test's safety and efficacy was based on a clinical study involving 292 CSF samples
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The samples were tested with Lumipulse and compared to amyloid PET scans
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In this clinical study, 97% of individuals who tested positive for Lumipulse had amyloid plaques found on PET scans, and 84% of individuals who tested negative for Lumipulse also had negative results on PET scans
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The FDA also pointed out that the test is not a screening test and cannot be used as a stand-alone diagnostic test
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There is the potential for positive results in healthy elderly individuals or in patients with other neurological disorders, so it is important to use this test with other clinical assessments
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"The use of in vitro diagnostic tests, potentially avoiding time-consuming and labor-intensive PET scans, is good news for individuals and families concerned about a possible diagnosis of Alzheimer's disease
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" Jeff Shuren, director of the FDA's Center for Medical Devices and Radiological Health "The Lumipulse test offers physicians a new option that can often be done within the same day, without the risk of radiation, and provides the same brain amyloid information (as a PET scan) to help determine a patient's identity," said Dr.
Whether cognitive impairment is due to Alzheimer's disease
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" Reference: [1] FDA Permits Marketing for New Test to Improve Diagnosis of Alzheimer's Disease.
Retrieved May 4, 2022, from https:// /press-announcements/fda-permits-marketing-new-test-improve-diagnosis-alzheimers-disease Disclaimer: The WuXi AppTec content team focuses on introducing global biomedical health research progress
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For guidance on treatment options, please visit a regular hospital
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