Quest will offer the first FDA-approved blood test to help detect Alzheimer’s-related amyloid pathology in patients with ...

The test is called the “Lumipulse G pTau217/ß-Amyloid 1-42 Plasma Ratio” and is developed by the Japanese company Fujirebio Diagnostics… The Food and Drug Administration (FDA) ...

Fujirebio Diagnostics Receives FDA Breakthrough Device Designation for Lumipulse® G β-Amyloid Ratio (1-42/1-40) Quantitative In Vitro Diagnostic Test ...

The FDA has granted 510(k) marketing clearance to the first in vitro blood-based biomarker diagnostic device for Alzheimer’s disease. Fujirebio’s Lumipulse G pTau217/ -Amyloid 1-42 Plasma ...

The Lumipulse test—which runs on Fujirebio’s G1200 lab instrument—measures the ratio of two specific beta-amyloid proteins, dubbed 1-42 and 1-40, that can accumulate in the brain and form ...

An FDA clinical study of 292 cereal spinal fluid samples from the Alzheimer’s Disease Neuroimaging Initiative sample bank tested by the Lumipulse G β-amyloid Ratio (1-42/1-40) and compared with ...

Last July, Fujirebio introduced the Lumipulse G GFAP assay in the US, a neurological research tool tailored for measuring glial fibrillary acidic protein (GFAP). "FDA grants 510(k) clearance to ...

CBS News - Video. FDA approves first blood test to help screen for Alzheimer's disease. Posted: May 19, 2025 | Last updated: May 19, 2025. The Lumipulse G Plasma Ratio Test offers a new way to ...

The Lumipulse G β-Amyloid Ratio test is indicated for use in adults aged 55 years and older with cognitive decline. ... J.D., director of the FDA’s Center for Devices and Radiological Health, ...

The company plans to make the diagnostic available to physicians and researchers this summer, expanding its portfolio beyond ...

Quest Diagnostics has signed up to offer a blood test that can help diagnose Alzheimer’s disease, following its FDA clearance earlier this year. | The Lumipulse G blood test measures the ratio between ...