Alzheimer’s Disease Diagnostic Test Approved for Marketing by FDA

Alzheimer's disease
Alzheimer’s Disease
Courtesy of Patrick Doheny (Flickr CC0)

Alzheimer’s disease’s first in vitro diagnostic test was granted to Breakthrough Device Designation. The U.S. Food and Drug Administration approved its marketing.

The amyloid plaques early detection diagnostic test called Lumipulse G β-Amyloid Ratio (1-42/1-40) is ideal for patients aged 55 years and older displaying cognitive impairment and other causalities of cognitive decline. Dr. Jeff Shuren, FDA’s Center for Devices and Radiological Health director 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. 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.

More than six million Americans have dementia caused by Alzheimer’s disease, a brain disorder known to gradually obliterate memory and thinking aptitudes and, ultimately, carry out the most straightforward chores. According to the National Institutes of Health, clinical manifestations first emerge in most people with Alzheimer’s disease.

Alzheimer’s disease

Alzheimer’s disease is a progressive condition and gets more alarming over time. Early and proper diagnosis to determine patients with amyloid plaques helps patients and caregivers plan early remedy alternatives. While amyloid plaques can also emerge in other illnesses, Alzheimer’s disease and further evaluations will allow doctors to specify the possible grounds of the patient’s symptoms. Doctors used to prefer positron emission tomography (PET) to see amyloid plaques in a patient’s brain scans, but it is a pricey and cumbersome choice.

Alzheimer’s Disease
Courtesy of NIH Image Gallery (Flickr CC0)

Lumipulse test

The Lumipulse test estimates the percentage of β-amyloid 1-42 and β-amyloid 1-40 proteins to form a plaque seen in human cerebrospinal fluid (CSF); a patient is likely to contain amyloid plaques in concurrence with the patient’s other clinical report.

A positive Lumipulse G β-amyloid Ratio (1-42/1-40) test result is constant with amyloid plaques, identical to a PET scan outcome. Negative test results decrease the probability of a patient’s cognitive impairment due to Alzheimer’s disease, allowing physicians to seek other mental causes of degeneration and dementia. The Lumipulse test should use other supplemental tests to decide on healthy alternatives. There is also the likelihood that a positive test outcome could be seen in patients with other neurologic disorders and older cognitively healthy individuals, which accentuates the significance of using this test with various clinical evaluations.

The FDA assessed the efficacy and safety of this test based on specimens taken from the sample bank of the Alzheimer’s Disease Neuroimaging Initiative. The threats associated with the Lumipulse G β-amyloid Ratio (1-42/1-40) test are mainly false positive and false negative test results. In conjunction with other clinical information, false-positive results could lead to an unsuitable diagnosis and unwarranted treatment that could lead to psychological despair, uncertainty in receiving an accurate diagnosis, and expenditure and the risk for side effects from undeserved remedy. False-negative test outcomes could mean additional undue diagnostic tests and treatment delays.

FDA Review

The FDA reevaluated the contraption through the De Novo premarket review pathway creating a new regulatory category. The succeeding identical gadgets may undergo FDA’s 510(k) premarket process to obtain marketing approval.

The FDA granted the Lumipulse G β-amyloid Ratio (1-42/1-40) a Breakthrough Device designation to speed up the progress and reexamine devices that equip more efficacious remedy or diagnosis of irreversibly debilitating or life-threatening conditions.

Written by Janet Grace Ortigas
Edited by Sheena Robertson


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Featured and Top Image Courtesy of Patrick Doheny’s Flickr Page – Creative Commons License
Inset Image by National Institute on Aging, NIH Courtesy of NIH Image Gallery‘s Flickr Page – Creative Commons License