FDA clears 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 to be approved for use in the United States measuring amyloid protein levels in spinal fluid.

Doctors and patients currently have very few tools to diagnose Alzheimer’s disease. Other than cognitive and psychological tests, the only way to diagnostically detect Alzheimer’s is to conduct a positron emission tomography (PET) scan. These scans can measure levels of damaging amyloid and tau proteins in the brain, but they are expensive and not accessible to many patients.

This new tool, called the Lumipulse test, can effectively detect levels of amyloid protein aggregations in the brain by looking for two specific amyloid proteins in cerebrospinal fluid. A clinical trial testing Lumipulse against PET scan results found it to be 97 percent accurate at picking up patients with brain amyloid aggregations.

“The development of accurate tests for AD [Alzheimer’s disease] using biomarkers found in the CSF or other bodily fluids is a requirement if we are to make real progress against this dreaded disease,” said William Hu, a researcher working on the development of the test. “The importance of early diagnosis in AD is widely acknowledged, but until now, there has been no approved biomarker test available to clinicians and patients.”

The Lumipulse test is certainly not a simple test. Collecting spinal fluid samples is not as easy a procedure as a blood test. However, the new test will make amyloid measurements substantially more accessible to more patients across the country.

A statement from the FDA indicates the test is only intended for adults aged over 55 years who are being evaluated by a doctor for Alzheimer’s disease. The test is not to be used as a general screening or diagnostic tool but instead it can help doctors rule out early-onset Alzheimer’s in patients presenting with neurological problems.

“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’s disease diagnosis,” said the FDA’s director of devices and radiological health, Jeff Shuren. “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.”

Sources: FDA, Fujirebio Diagnostics