One of the First US In Vitro Diagnostic Tests for Assessment of Alzheimer Disease


The Lumipulse® G β-Amyloid Ratio in vitro diagnostic test was filed for 510(k) premarket clearance.


The Lumipulse® G β-Amyloid Ratio in vitro diagnostic test was filed for 510(k) premarket clearance with the US Food and Drug Administration (FDA), Fujirebio Diagnostics, Inc, announced today. In February 2019, the test was granted Breakthrough Device Designation. It is expected to be one of the first US in vitro diagnostic tests for the assessment of Alzheimer disease.

“The lack of effective and accessible clinical tools for patients who could be on the pathway to develop Alzheimer disease contributes to its late diagnosis and inadequate treatment,” Monte Wiltse, President and CEO at Fujirebio Diagnostics, said to the press. “We designed our Lumipulse® G β-Amyloid Ratio test to help physicians triage their patient much sooner when effective interventions are more feasible using these well- researched β-amyloid biomarkers. Accurate and earlier intervention will also facilitate the development of new drug therapies, which are urgently needed as the prevalence of Alzheimer disease increases with a rapidly aging population globally.”1

Alzheimer disease is diagnosed in more than 5 million Americans, with few treatments available until their disease is further advanced. Current tools, like amyloid PET imaging, can be expensive, time consuming, and hard to access.

The Lumipulse G β-Amyloid Ratio is reported to merge the concentrations of Lumipulse G β-Amyloid 1-42 and Lumipulse G β-Amyloid 1-40 found in human cerebral spinal fluid (CSF). It is intended for use in patients aged 50 years and over who present with cognitive impairment and are being evaluated for Alzheimer disease. It is also not intended for sole use, but rather to be used in conjunction with other diagnostic modalities. Fujirebio’s fully automated LUMIPULSE® G1200 instrument system analyzes the test.

It is the hope of researchers that better diagnostics will spur the developments of further treatments options.


1. Fujirebio Diagnostics. Fujirebio Diagnostics Files 510(k) With FDA for Lumipulse® G β-Amyloid Ratio (1-42/1-40) In Vitro Diagnostic Test. News release. December 2, 2020.

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