Roche receives FDA clearance for additional Alzheimer’s disease Cerebrospinal Fluid (CSF) assays, supporting timely diagnosis and treatment decision-making

Roche, a leading biotechnology company, has obtained clearance from the U.S. Food and Drug Administration (FDA) for other Alzheimer’s disease Cerebrospinal Fluid (CSF) assays. The newly cleared assays, known as Elecsys tTau/Abeta42 ratio, are crucial in enabling timely diagnosis and facilitating treatment decisions for Alzheimer’s disease.

The Elecsys tTau/Abeta42 ratio is designed to assist clinicians in biologically defining Alzheimer’s disease. By measuring the levels of beta-amyloid and tau proteins, and the biomarkers associated with the disease, the assays provide valuable insights into the three main pathological processes of Alzheimer’s: amyloid plaques, tau tangles, and neurodegeneration.

These biomarker assays are recommended for confirming amyloid pathology, particularly in the context of new and emerging disease-modifying therapies (DMTs) that have shown efficacy in slowing down cognitive decline when administered during the early stages of the disease. The Elecsys AD CSF assays can be seamlessly integrated into Roche’s widely available cobas fully automated immunoassay analyzers, ensuring broad access to high-quality patient testing promptly.

The President and CEO of Roche Diagnostics North America, Brad Moore, highlights the importance of early and accurate diagnosis for patients, caregivers, and physicians in determining the appropriate treatment path. The Elecsys CSF assays enable diagnosis at early disease stages, where interventions can have the most significant impact.

Alzheimer’s disease follows a progressive continuum, with symptoms worsening over time. To support the use of new Alzheimer’s-specific therapies, the confirmation of amyloid pathology is essential. The Elecsys AD CSF assays offer an accessible and cost-effective alternative to amyloid positron emission tomography (PET) scans, providing reliable detection of both amyloid and tau biomarkers from a single draw without exposing patients to radiation. Compared to PET scans, which require multiple appointments and procedures and have limited availability, the Elecsys assays offer a streamlined and more accessible option.

Roche’s Elecsys AD CSF assays have already received clearance in 46 countries worldwide, including those accepting the CE mark. In addition to these CSF assays, Roche is also developing an innovative blood-based test, the Elecsys Amyloid Plasma Panel, which the FDA has granted Breakthrough Device Designation. Once available, this test could further streamline the diagnostic pathway by measuring Alzheimer’s biomarkers from a blood sample.

Roche, founded in 1896 and headquartered in Basel, Switzerland, is the world’s largest biotechnology company and a leader in in-vitro diagnostics. They are dedicated to scientific excellence and personalized healthcare, striving to improve and save lives globally. Roche’s commitment to sustainability and access to healthcare has been recognized consistently by the Dow Jones Sustainability Indices.

References:

• https://diagnostics.roche.com/us/en/news-listing/2023/roche-fda-clearance-additional-alzheimers-disease-cerebrospinal-fluid-ttau.html?utm_source=pr&utm_medium=li&utm_campaign=ad