Fujirebio seeks FDA approval of blood test for Alzheimer’s
Test would be first of its kind commercially available
Fujirebio Diagnostics asked the U.S. Food and Drug Administration (FDA) to approve its Alzheimer’s disease diagnostic blood test, Lumipulse G pTau 217/β [beta]-Amyloid 1-42 Plasma Ratio.
If approved, the test would be the first commercially available blood-based in vitro test in the U.S. to aid in diagnosing Alzheimer’s disease, according to the company. It combines two individual tests to measure levels of p-Tau 217 and beta-amyloid 1-42 in the blood, providing their ratio as an output.
The company said new test complements the Lumipulse G β-Amyloid Ratio (1-42/1-40), which the FDA approved in 2022 to detect amyloid plaques in cerebrospinal fluid, the fluid found within the tissue that surrounds the brain and spinal cord.
“The lack of effective and accessible diagnostics for [Alzheimer’s] contributes to its late diagnosis and inadequate treatment,” Monte Wiltse, Fujirebio Diagnostics’ president and CEO, said in a company press release. The test was designed “to help physicians and patients with signs and symptoms of cognitive decline obtain an [Alzheimer’s] diagnosis much earlier when interventions are more effective,” Wiltse said.
Tangles in the brain
Alzheimer’s disease occurs when two proteins, beta-amyloid and tau, form harmful plaques and tangles in the brain. These accumulations disrupt normal brain function and result in the loss of nerve cells, which is believed to be the underlying cause of the disease’s symptoms. The buildup of these proteins can be measured using brain scans and analyzing cerebrospinal fluid. However, these approaches are expensive and invasive.
Accurate and affordable blood-based diagnostic tests could aid in early diagnosis, and that “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 said.
This test measures the levels of p-Tau217, a modified form of the tau protein that is a component of the tau tangles seen in Alzheimer’s and is considered an early blood biomarker of the disease. It also measures the levels of beta-amyloid 1-42, a fragment of a larger protein called amyloid precursor protein and the main component of amyloid plaques.
The FDA has granted the test breakthrough device designation, a status given to new medical technologies that may provide more effective diagnosis or treatment for life-threatening or debilitating diseases than those currently available. It allows for prioritized review on subsequent submissions to speed the development process.
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