FDA approves marketing for first test to improve diagnosis of Alzheimer's disease

The U.S. Food and Drug Administration said yesterday that it has approved the marketing of the first test to improve the diagnosis of Alzheimer's disease.

The Lumipluse test from Fujirebio Diagnostics, the FDA said, tests for early detection of amyloid plaques associated with Alzheimer's disease.

It is intended to be used in adults age 55 and older who are experiencing cognitive impairment and being evaluated for Alzheimer's and other causes of "cognitive decline."

"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 Jeff Shuren, M.D., J.D., director of the FDA'sCenter 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's disease."

The FDA said that, "According to the National Institutes of Health, more than six million Americans, most age 65 or older, may have dementia caused by Alzheimer's disease, a brain disorder known to slowly destroy memory and thinking skills, and, eventually, the ability to carry out the simplest tasks. In most people with Alzheimer's disease, clinical symptoms first appear later in life.

Alzheimer's disease is progressive, meaning that the disease gets worse over time.  Early and accurate diagnosis is important to help patients and caregivers with planning and early treatment options. There is an unmet need for a reliable and safe test that can accurately identify patients with amyloid plaques consistent with Alzheimer's disease. While amyloid plaques can occur in other diseases, being able to detect the presence of plaque, along with other evaluations, helps the doctor determine the probable cause of the patient's symptoms and findings."

The FDA said doctors have used PET scans, which can be costly and cumbersome, to detect amyloid plaques in a patient's brain.

A negative test, the FDA said, "reduces the likelihood that a patient's cognitive impairment is due to Alzheimer's disease, enabling physicians to pursue other causes of cognitive decline and dementia."

The FDA noted the primary risk with the test is the possibility of false results. The FDA said the test should be used in conjunction with other evaluations and tests.

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