Fujirebio Seeks FDA’s Premarket Approval for Diagnostic Test

Fujirebio Diagnostics has submitted a premarket notification — also known as a 510(k) — to the U.S. Food and Drug Administration (FDA) for its Alzheimer’s diagnostic test, called Lumipulse G β-Amyloid Ratio (1-42/1-40).

If cleared by the FDA, it will be among the first commercially available lab tests to assess the risk of Alzheimer’s disease in adults with signs of cognitive impairment.

The new Lumipulse G β [beta]-Amyloid ratio combines two individual tests, the Lumipulse G β-amyloid 1-42 and the Lumipulse G β-amyloid 1-40. Each test measures the levels of a different form of the beta-amyloid protein — beta-amyloid 42 and beta-amyloid 40 — in the cerebral spinal fluid (CSF), which is the liquid surrounding the brain and spinal cord. This fluid is collected using a lumbar puncture procedure, also called a spinal tap.

Beta-amyloid is the main constituent of amyloid plaques, or clumps, in the brain, one of the main features of Alzheimer’s disease. Evidence suggests that the accumulation of beta-amyloid in the brain disrupts several brain functions and eventually leads to the death of nerve cells (neurons).

The test output is the ratio of beta-amyloid 1-42/1-40 in the CSF and is intended for use in adults, ages 50 and older, with signs of cognitive impairment, who are being tested for Alzheimer’s disease or other causes of cognitive decline.

“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 at Fujirebio Diagnostics, said in a press release.

“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,” he said.

“Accurate and earlier intervention will also facilitate the development of new drug therapies, which are urgently needed as the prevalence of Alzheimer’s disease increases with a rapidly aging population globally,” Wiltse added.

The FDA had granted breakthrough device designation to the diagnostic test in February 2019. That designation is awarded to new medical technologies that may provide more effective treatment or diagnosis for life-threatening or debilitating diseases or conditions than what is currently available. It allows for prioritized review on subsequent submissions to speed up product development.

The Lumipulse G β-Amyloid test and tests measuring the levels of the tau protein — whose accumulation is also a hallmark of Alzheimer’s disease — are already approved for use in the European Union.