Monday, May 9, 2022

FDA Clears Cerebrospinal Fluid Test to Help Diagnose Alzheimer’s Disease

Last week, the Food and Drug Administration (FDA) cleared for marketing the first biomarker-based diagnostic test for Alzheimer’s disease.

The Lumipulse G β-Amyloid Ratio (1-42/1-40) test, manufactured by Fugirebio Diagnostics Inc., measures two variants of the amyloid beta protein in cerebrospinal fluid. A positive result suggests that a patient may have amyloid plaques in the brain associated with Alzheimer’s disease. The cerebrospinal fluid is obtained through a spinal tap, which can usually be performed on an outpatient basis. Currently, amyloid plaques can be identified only with positron emission tomography (PET) brain scans, a process that can be time consuming and expensive.

“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’s disease,” commented Jeff Shuren, M.D., J.D., director of the FDA’s Center for Devices and Radiological Health, in a media release.

The Lumipulse test is intended for use in adults aged 55 years and older with cognitive impairment who are being evaluated for Alzheimer’s disease and other causes of cognitive decline. According to the FDA, the Lumipulse test should not be used by itself to diagnose Alzheimer’s and should instead be used as part of a comprehensive evaluation. As noted by the FDA, amyloid plaques may be present in other neurological conditions as well as in some older patients who are cognitively healthy.

The FDA approved the Lumipulse test following a study of cerebrospinal fluid samples from 292 older adults participating in the Alzheimer’s Disease Neuroimaging Initiative. In this clinical study, 97% of adults with a positive Lumipulse test had amyloid plaques in their brains as confirmed by PET scan, while only 16% of adults with a negative Lumipulse test had confirmed amyloid plaques.

For related information, see the Psychiatric News article “Alzheimer’s Blood Test Shows Clinical Potential.”

(Image: iStock/fizkes)

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