• The Elecsys^® tTau/Abeta42 ratio helps clinicians define Alzheimer's disease (AD) biologically and expands Roche's AD CSF portfolio to include biomarkers for all three main pathological processes of Alzheimer's: amyloid plaques, tau tangles and neurodegeneration.
• Confirmation of amyloid pathology via CSF FDA-cleared Alzheimer's biomarker testing or amyloid positron emission tomography (PET) is recommended in the appropriate use recommendations for new and emerging disease-modifying therapies (DMTs) shown to slow down cognitive decline when administered in early-disease stages.
• Scalable and economical, Elecsys AD CSF assays can be added to any of Roche's widely available cobas^® fully automated immunoassay analyzers, giving patients broad access to high-quality testing in a timely manner.

Currently, the diagnosis of Alzheimer's is largely one of exclusion (ruling out non-Alzheimer's causes of symptoms) based on a number of evaluations, including various cognitive exams, routine laboratory tests and neuroimaging with a head MRI or CT scan. Obtaining an accurate diagnosis can take years,¹ and one based on clinical criteria is reached only 70%-80% of the time.² Additional evaluations with biomarkers specific to Alzheimer's improve medical decisions, as they can identify underlying pathological changes early in 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^® beta-Amyloid (1-42) CSF II (Abeta42) and Elecsys^® Phospho-Tau (181P) CSF (pTau181) assays (used as a pTau181/Abeta42 ratio) that received FDA 510(k) clearance in 2022 and Elecsys beta-Amyloid (1-42) CSF II and Elecsys Total-Tau CSF assays (the tTau/Abeta42 ratio) are reflective of the main Alzheimer's pathologies and help clinicians more completely define the disease biologically, facilitating a diagnosis of inclusion.

"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," said Brad Moore, president and CEO of Roche Diagnostics North America. "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."

Progression of Alzheimer's occurs over a continuum with symptoms worsening over time. The Alzheimer's Association estimates that, each day, more than 2,000 people ages 65 and older may transition from mild dementia due to Alzheimer's to moderate dementia due to Alzheimer's.³

The appropriate use recommendations for new and emerging Alzheimer's medicines call for confirmation of amyloid pathology.⁴ The only FDA-cleared methods to confirm amyloid pathology are CSF tests and PET scan imaging.

The Elecsys AD CSF assays are concordant with amyloid PET scan imaging⁵ 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.⁶ The high cost, limited availability and patient exposure to radioactivity limit use and accessibility to PET. In addition, evaluating both amyloid and tau Alzheimer's biomarkers using PET requires multiple appointments and procedures, and increases radiation exposure.

The Elecsys pTau181/Abeta42 ratio is currently available. The new Elecsys tTau/Abeta42 ratio will be available in Q4 2023. Roche's Elecsys AD CSF assays are already registered in 46 countries worldwide, including those accepting the CE mark. In July 2022, Roche also announced that the FDA granted Breakthrough Device Designation to its Elecsys^® Amyloid Plasma Panel, an innovative, minimally invasive and easily accessible solution that enables the measurement of Alzheimer's biomarkers from a blood sample. These assays are still in development, but once they are available, they could be used to streamline patients toward confirmation of amyloid pathology using the Elecsys AD CSF assays.