Alzheimer’s: the US FDA authorizes the first blood diagnostic test for the disease

Alzheimers the US FDA authorizes the first blood diagnostic test

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    Dr Christophe de Jaeger (Longevity and geriatrics)

    A blood test to be performed in vitro to detect Alzheimer’s disease has just been authorized by the Food and Drug Administration (FDA) in the United States. “A real breakthrough for the early diagnosis of the disease” welcomes Dr. Christophe De Jaeger, physiologist and member of the committee of experts of Doctissimo.

    Based on the principle of detecting amyloid plaques – which are associated with Alzheimer’s disease – in the plasma thanks to a simple blood test, this Roche laboratory test was authorized by the FDA, in this month of July 2022.

    Alzheimer’s: a faster and more reliable test

    Indeed, it is by means of a press release that Roche laboratories officially announce today that they have obtained “FDA’s “Innovative Device” designation for their Elecsys Amyloid Plasma Panel test“, capable of detecting and measuring “biomarkers of Alzheimer’s disease in blood plasmaRoche is the first in vitro diagnostics manufacturer to receive this designation for a blood biomarker test for Alzheimer’s disease.

    A serious and disabling illness

    Alzheimer’s disease is a serious and progressive pathology that affects the cognitive abilities of the sick person. Until now, it is thanks to a long and expensive medical imaging examination, called positron emission tomography (PET), that the diagnosis was made in the United States. Remember that across the Atlantic, more than six million Americans aged 65 or over are affected by dementia caused by Alzheimer’s disease.

    Help with early diagnosis

    To help in the early and simplified diagnosis of the disease, a rapid screening test must be developed. There is already a test that requires performing a lumbar puncture to analyze the cerebrospinal fluid.

    But for this screening test, it is a simple blood test that is carried out. The Elecsys Amyloid Plasma panel will be the first qualitative test to combine the result of the phosphorylated protein Tau (pTau) 181 assay and the apolipoprotein (APOE) E4 assay in human plasma. Elevations in pTau occur in the early stages of Alzheimer’s disease, while the presence of APOE E4 is the most common genetic risk factor for Alzheimer’s disease.

    Our new diagnostic test has the potential to streamline a patient’s journey. , improving speed and access to a confirmatory diagnosis, giving people with Alzheimer’s disease and their caregivers more time to plan and prepare for the future” says Thomas Schinecker, CEO of Roche Diagnostics.

    The role of the doctor remains essential

    For Dr. Christophe De Jaeger, physiologist and member of the Doctissimo expert committee, this is a real scientific breakthrough. “This test will really get things going routinely, as it is easy to prescribe a blood test. This will allow many patients to be diagnosed more quickly and therefore more quickly taken care of, depending on their clinical state of health and their disorders. he details. For him, “the role of the doctor will be to determine the relevance of the results and to see whether or not an Alzheimer’s disease can be suspected, because the diagnosis of Alzheimer’s is complex and it is necessary to know how to question it”.


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