Fujirebio Seeks FDA’s Premarket Approval for Diagnostic Test

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 interv
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