Sam Brusco, Associate Editor06.27.23
Roche has received U.S. Food and Drug Administration (FDA) 510(k) clearance for its Elecsys beta-Amyloid (1-42) CSF II (Abeta42) and Elecsys Total-Tau CSF assays (tTau). The assays measure two biomarkers of Alzheimer’s pathology—beta-amyloid and tau proteins—in adults aged 55 and over being evaluated for the disease.
Roche’s FDA-cleared Alzheimer’s tests in the U.S. include two ratios comprising three assays, and both ratios include Abeta42.
"With the increasing likelihood of broad availability of new, Alzheimer's disease–specific therapies, now is the time for healthcare professionals and institutions to prepare to meet the demand for diagnostic methods to streamline and accelerate the path to the right treatment, at the right time, for people with Alzheimer's," Brad Moore, president and CEO of Roche Diagnostics North America told the press. "An early and accurate diagnosis can help patients, caregivers and physicians determine a path forward, and the Elecsys CSF assays support diagnosis at early disease stages, when treatment is most effective."
The Elecsys AD CSF assays are concordant with amyloid PET scan imaging and could offer a more affordable, accessible routine option to confirm presence of amyloid pathology in the brain. They detect amyloid and tau biomarkers in one draw, without radiation and with possibility of detecting Alzheimer’s pathology in the disease’s early stages.
The Elecsys beta-Amyloid (1-42) CSF II and Total–Tau CSF assays accurately, reliably measure the beta–Amyloid (1–42) and Total–Tau concentrations in CSF in adults aged 55 and older being evaluated for Alzheimer's disease and other causes of cognitive impairment to generate a tTau/Abeta42 ratio value. As changes in these biomarkers levels occur at the disease’s early stages, the assays can detect Alzheimer's pathology in earlier stages of disease (e.g., mild cognitive impairment).
Elecsys tTau and Elecsys Abeta42 assays are both traceable to reference materials, ensuring accuracy of the tTau/Abeta42 ratio results.
Roche’s FDA-cleared Alzheimer’s tests in the U.S. include two ratios comprising three assays, and both ratios include Abeta42.
"With the increasing likelihood of broad availability of new, Alzheimer's disease–specific therapies, now is the time for healthcare professionals and institutions to prepare to meet the demand for diagnostic methods to streamline and accelerate the path to the right treatment, at the right time, for people with Alzheimer's," Brad Moore, president and CEO of Roche Diagnostics North America told the press. "An early and accurate diagnosis can help patients, caregivers and physicians determine a path forward, and the Elecsys CSF assays support diagnosis at early disease stages, when treatment is most effective."
The Elecsys AD CSF assays are concordant with amyloid PET scan imaging and could offer a more affordable, accessible routine option to confirm presence of amyloid pathology in the brain. They detect amyloid and tau biomarkers in one draw, without radiation and with possibility of detecting Alzheimer’s pathology in the disease’s early stages.
The Elecsys beta-Amyloid (1-42) CSF II and Total–Tau CSF assays accurately, reliably measure the beta–Amyloid (1–42) and Total–Tau concentrations in CSF in adults aged 55 and older being evaluated for Alzheimer's disease and other causes of cognitive impairment to generate a tTau/Abeta42 ratio value. As changes in these biomarkers levels occur at the disease’s early stages, the assays can detect Alzheimer's pathology in earlier stages of disease (e.g., mild cognitive impairment).
Elecsys tTau and Elecsys Abeta42 assays are both traceable to reference materials, ensuring accuracy of the tTau/Abeta42 ratio results.