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FDA approves marketing for new Alzheimer's early detection test

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DEDHAM, MA - OCTOBER 16: Intern Susan Garner-Titus helps New Bridge on the Charles Assisted Living resident Irving as he takes part in a class called Glued Together as part of an art and music therapy sessions for Alzheimer patients on October 16, 20 The Food and Drug Administration has approved marketing for the first in vitro diagnostic test for early detection of Alzheimer’s disease.FDA PUTS NEW LIMITS ON JOHNSON & JOHNSON VACCINE DUE TO RARE BLOOD CLOTTING CONDITIONThe Lumipulse G β-Amyloid Ratio (1-42/1-40) test is available at clinical laboratories nationwide for adult patients aged 55 years and older who are presenting with cognitive impairment and being evaluated for Alzheimer’s disease and other causes of cognitive decline.

The test, which is developed by Fujirebio Diagnostics Inc., is intended to measure the ratio of β-amyloid 1-42 and β-amyloid 1-40 proteins found in human cerebral spinal fluid, which can help physicians determine whether a patient is likely to have amyloid plaques.

β-amyloid plaques are believed to contribute to the loss of cognitive function that characterizes Alzheimer's disease.Fujirebio’s fully automated LUMIPULSE® G1200 system will analyze the Lumipulse G β-Amyloid Ratio (1-42/1-40) test for Alzheimer's disease.

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