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Roche Says FDA Clears Additional Alzheimer's Disease Cerebrospinal Fluid Assays
(RTTNews) - Swiss drug major Roche Holding AG (RHHBY) announced Tuesday that its Elecsys beta-Amyloid (1-42) CSF II (Abeta42) and Elecsys Total-Tau CSF assays (tTau) have received U.S. Food and Drug Administration (FDA) 510(k) clearance.
The Elecsys AD CSF Abeta42 and tTau assays (used as a tTau/Abeta42 ratio) measure two biomarkers of Alzheimer's pathology, beta-amyloid and tau proteins, in adults ages 55 and older being evaluated for the disease.
Roche's FDA-cleared Alzheimer's tests in the U.S. include two ratios comprising three assays. Both ratios include Abeta42.
The Elecsys AD CSF assays are concordant with amyloid PET scan imaging and have the potential to provide a more affordable and accessible routine option to confirm the presence of amyloid pathology in the brain.
They also offer detection of both amyloid and tau biomarkers from one draw, with no radiation and potential to detect Alzheimer's pathology in early stages of disease.
The Elecsys pTau181/Abeta42 ratio is currently available, while the new Elecsys tTau/Abeta42 ratio will be available in the fourth quarter of 2023.
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