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Fujirebio Diagnostics Applies for FDA 510(k) Clearance for Alzheimer's Disease Test

NEW YORK ─ Fujirebio Diagnostics on Wednesday announced it has applied to the US Food and Drug Administration for clearance for its Lumipulse G β-Amyloid Ratio (1-42/1-40) diagnostic test.

The firm said it anticipates that the test, if cleared, would be among the first commercially available in vitro diagnostic assays in the US to help in the assessment of Alzheimer’s disease.

The test runs on the firm's fully automated Lumipulse G1200 instrument.

It combines concentrations of Lumipulse G β-Amyloid 1-42 and Lumipulse G β-Amyloid 1-40 in human cerebral spinal fluid into a numerical ratio of β-Amyloid1-42/ β-Amyloid1-40, leading to a semiquantitative assay for adults aged 50 years-and-over who present with cognitive impairment and are being evaluated for Alzheimer’s disease and other causes of cognitive decline, Fujirebio Diagnostics said.  

"The lack of effective and accessible clinical tools for patients who could be on the pathway to develop Alzheimer’s disease contributes to its late diagnosis and inadequate treatment," Monte Wiltse, president and CEO of Fujirebio Diagnostics, said in a statement. "We designed our Lumipulse G β-Amyloid Ratio test to help physicians triage their patients much sooner when effective interventions are more feasible using these well-researched β-amyloid biomarkers."

Accurate and earlier intervention would facilitate the development of new drug therapies, he added.

In February 2019, the Malvern, Pennsylvania-based firm received FDA Breakthrough Device Designation for its Alzheimer's disease test.

The firm's Lumipulse G β-Amyloid and Tau tests are CE-marked, enabling their use in the European Union and other regions that accept the designation.

Fujirebio Diagnostics is a wholly-owned subsidiary of Fujirebio Holdings and HU Group Holdings, both based in Tokyo.