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Breakthrough in Alzheimer’s disease diagnosis: FDA authorizes diagnostic test for β-amyloid plaques

The U.S. Food and Drug Administration (FDA) has authorized the marketing of the Fujirebio’s Lumipulse G β-Amyloid Ratio (1-42/1-40) in vitro diagnostic test for the assessment of β-amyloid pathology in patients being evaluated for Alzheimer’s disease and other causes of cognitive decline.

Alzheimer’s disease (AD) is a progressive, neurodegenerative disease characterized by the presence of β-amyloid plaques in the brain. According to the World Health Organization, AD causes around 60-70% of dementia cases and is a major cause of dependency among older people globally.1 

Early diagnosis allows strategies to be implemented for the care, management, and future treatment of AD patients. This alleviates the physical, psychological, social, and economic burden of AD in both an individual and societal context. Indeed, the Alzheimer’s Association concluded that early diagnosis of AD could save around $7 trillion.2 However, AD diagnosis has proved difficult. Diagnosis tests for AD patients are expensive, time-consuming, and not consistently accurate. AD diagnosis relies heavily on ruling out other physical and medical causes, cognitive and functional assessments, and positron emission tomography (PET) scans – until now, the only way to detect and visualize β-amyloid plaques in a patient’s brain.3,4  

The Lumipulse test is intended to measure the concentrations of β-amyloid 1-42 and β-amyloid 1-40 in the cerebrospinal fluid (CSF) of adults aged 55 years and older who are being evaluated for AD. A numerical ratio between the two forms of β-amyloid can consequently be calculated to determine the status of β-amyloid plaques in the brain. A positive or negative test has been shown to be consistent with the presence or absence of amyloid plaques, similar to a PET scan. Due to the possibility of false positive and false negative test results, the Lumipulse test results must be interpreted together with other patient clinical information or additional tests. The FDA notes that “the test is not intended as a screening or stand-alone diagnostic assay”.4

The safety and effectiveness of the test were evaluated in a clinical study, which utilized 292 CSF samples from the Alzheimer’s Disease Neuroimaging Initiative (ADNI) sample bank. The samples were tested by the Lumipulse test and compared with β-amyloid PET scan results. In the study, 97% of participants with a positive Lumipulse test result had β -amyloid plaques detected by PET scans, while 84% of participants with a negative result had a negative β-amyloid PET scan.4 Therefore, the Lumipulse test offers an alternative to PET scans allowing to reduce diagnosis time, cost, and the level of radiation that patients usually receive. 

The approval of this test is significant as it has the potential to bring all the advantages of early AD diagnosis. Indeed, Monte Wiltse, president, and CEO at Fujirebio describes the approval and upcoming launch of this test as “important milestones in the campaign to transform AD into a manageable disease”.5

Written by Laura Bassett

Edited by Marta Palhas

References:

  1. World Health Organisation. Dementia. Available from: https://www.who.int/news-room/fact-sheets/detail/dementia Last accessed: 17/05/2022
  2. Alzheimer’s Association. 2020 Alzheimer’s disease facts and figures. Alzheimer’s Dement. Mar 2020;16:391–460.
  3. Porsteinsson, A.P., Isaacson, R.S., Knox, S. et al. Diagnosis of Early Alzheimer’s Disease: Clinical Practice in 2021. J Prev Alzheimers Dis. 2021;8, 371–386.
  4. FDA. FDA Permits Marketing for New Test to Improve Diagnosis of Alzheimer’s Disease [Press Release]. Available from: https://www.fda.gov/news-events/press-announcements/fda-permits-marketing-new-test-improve-diagnosis-alzheimers-disease?utm_campaign=FDA+Permits+Marketing+for+New+Test+to+Improve+Diagnosis+of+Alzhe&utm_medium=email&utm_source=govdelivery Last accessed: 18/05/2022
  5. Fujirebio. Lumipulse® G β-Amyloid Ratio (1-42/1-40) in vitro diagnostic test receives FDA marketing authorization for the assessment of Alzheimer’s disease in the United States [Press Release]. Available from: https://www.fujirebio.com/en/news-events/lumipulser-g-bamyloid-ratio-142140-in-vitro-diagnostic-test-receives-fda-marketing Last accessed: 17/05/2022