FDA Oks Marketing Of First In Vitro Diagnostic Test To Detect Alzheimer’s Disease

The U.S. Food and Drug Administration or FDA granted marketing authorization for the first in vitro diagnostic test for early detection of amyloid plaques associated with Alzheimer’s disease using the De Novo review pathway, the traditional premarket review process for low- to moderate-risk devices of a new type.

The FDA permitted marketing of the Lumipulse G ß-Amyloid Ratio (1-42/1-40) test to Fujirebio Diagnostics, Inc.

The Lumipulse test is intended to be used in adult patients, aged 55 years and older, presenting with cognitive impairment who are being evaluated for Alzheimer’s disease and other causes of cognitive decline.

The FDA said 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.

The Lumipulse test 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 determine if a patient’s cognitive impairment is due to Alzheimer’s disease.

The Lumipulse test offers an alternative to the current standard for determining amyloid-pathology, amyloid positron emission tomography (PET) brain imaging which is expensive, subjective, time consuming, inaccessible to many Americans, and often not covered by health insurance

A positive Lumipulse G ß-amyloid Ratio (1-42/1-40) test result is consistent with the presence of amyloid plaques, similar to what would be seen in a PET scan. A negative result is consistent with a negative amyloid PET scan result.

The FDA evaluated the safety and effectiveness of this test in a clinical study of 292 CSF samples from the Alzheimer’s Disease Neuroimaging Initiative sample bank. The samples were tested by the Lumipulse G ß-amyloid Ratio (1-42/1-40) and compared with amyloid PET scan results.

In this clinical study, 97% of individuals with Lumipulse G ß-amyloid Ratio (1-42/1-40) positive results had the presence of amyloid plaques by PET scan and 84% of individuals with negative results had a negative amyloid PET scan.

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.

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, according to the National Institutes of Health. The number is expected to triple to almost 14 million by 2050.

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