(CercleFinance.com) – Roche today announced that its Elecsys ® beta-Amyloid (1-42) CSF II (Abeta42) and Elecsys ® Phospho -Tau (181P) CSF (pTau181) test products have received regulatory approval. United States Food and Drug Administration (FDA).
The Elecsys AD CSF Abeta42 and pTau181 assays measure two hallmark biomarkers of Alzheimer’s disease, beta-amyloid and tau proteins, in adults aged 55 years and older being assessed for the disease.
Currently, the diagnosis of Alzheimer’s disease is a diagnosis of exclusion, largely based on various cognitive tests, routine laboratory tests and structural imaging (MRI or CT scan).
The clinical criteria are currently limited and only lead to a precise diagnosis in 70 to 80% of cases. To increase diagnostic accuracy, an amyloid positron emission tomography (PET), which measures abnormal beta-amyloid protein accumulation in the brain, may be used in addition to these assessments.
Elecsys AD CSF tests achieve 90% concordance with amyloid PET imaging and have the potential to provide a more affordable and accessible routine option for confirming the presence of amyloid in the brain.
‘Globally, up to 75% of people living with Alzheimer’s disease have not been diagnosed, and those who have it often report a long and complicated process,’ said Thomas Schinecker, CEO of Roche Diagnostics.
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