Fujirebio today announced that the U.S. Food and Drug Administration (FDA) has granted 510(k) clearance for the company’s ...

(BUSINESS WIRE )--Fujirebio today announced that the U.S. Food and Drug Administration (FDA) has granted 510(k) clearance for the company's Lumipulse ® G pTau 217/β-Amyloid 1-42 Plasma Ratio in ...

The test is performed on Quanterix’s SP-X platform with the Quanterix Simoa assay kit, which uses pTau 217 antibody technology licensed from Eli Lilly.

The US Food and Drug Administration (FDA) has awarded 510(k) clearance to Fujirebio’s Lumipulse G pTau 217/β-Amyloid 1-42 ...

Since Alzheimer's disease affects over 7 million people in the U.S., potentially doubling to 14 million by 2050, earlier ...

The blood test, known as the Lumipulse G pTau 217/β-Amyloid 1-42 Plasma Ratio, can be used to detect amyloid plaques ...

The US Food and Drug Administration (FDA) has awarded 510(k) clearance to Fujirebio’s Lumipulse G pTau 217/β-Amyloid 1-42 Plasma Ratio in vitro diagnostic (IVD) test for evaluating amyloid ...

First Blood-Based In-Vitro Diagnostic Test to Receive FDA Clearancefor Patients Being Assessed for Alzheimer's Disease. --Availability of Accurate ...

The very first blood test for Alzheimer's disease detection has been green-lit by the US Food and Drug Administration (FDA), ...

The US Food and Drug Administration (FDA) has approved Fujirebio Diagnostics’ Alzheimer’s disease (AD) blood test to help ...

The FDA said it has issued its first official green light for a blood test to help diagnose Alzheimer’s disease, adding that ...