FDA grants Breakthrough Device Designation for Roche’s Elecsys cerebrospinal fluid (CSF) assays to support the improved diagnosis of Alzheimer’s disease

FDA grants Breakthrough Device Designation for Roche’s Elecsys cerebrospinal fluid (CSF) assays to support the improved diagnosis of Alzheimer’s disease

Roche announced today, that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Device Designation to Elecsys ß-Amyloid (1-42) CSF and Elecsys Phospho-Tau (181P) CSF. These in vitro diagnostic immunoassays are for the measurement of the ß-Amyloid (1-42) and Phospho-Tau concentrations in cerebrospinal fluid (CSF) in adult patients with cognitive impairment who are being evaluated for Alzheimer’s disease (AD) or other causes of dementia.

Currently, the diagnosis of AD is largely based on clinical symptoms, including cognitive testing, with a significant number of patients diagnosed when their disease has already advanced. A diagnosis of AD based on cognitive measures alone is only correct in 70 – 80 percent of cases. Measuring biomarkers with CSF immunoassays, associated with AD pathology, increases certainty of a diagnosis of AD and can help to evaluate the progression of the disease. The Breakthrough Device Designations are for indication of use with Elecsys β-Amyloid (1-42) CSF and Elecsys Phospho-Tau (181P) CSF in concordance with amyloid PET visual read result and risk of cognitive or functional decline. The Breakthrough Devices Program is a voluntary program for certain medical devices that provide for more effective treatment or diagnosis of a life-threatening or irreversibly debilitating disease or condition. This program is designed to expedite the development and review of these medical devices.

“We are excited about FDA’s recognition of the potential clinical benefit the Elecsys CSF assays can bring to clinicians, laboratories and their patients in diagnosing AD at an early stage,” said Roland Diggelmann, CEO of Roche Diagnostics. “Roche was one of the first companies to use biomarkers in clinical trials and we will continue to explore high-performing diagnostic and disease-monitoring solutions.”

About Elecsys CSF immunoassays

Establishing the presence of degenerative diseases of the central nervous system is important when it comes to distinguishing age-related memory disorders from early-stage dementia. Deposits of β-amyloid peptides (1-42) and neurofibrillary tangles in the brain are the two earliest changes associated with the development of Alzheimer's disease and can be detected by different methods. Biomarkers in the cerebrospinal fluid (CSF) help clinicians detect Alzheimer’s disease, the most common form of dementia, from an earlier stage. Currently available for countries accepting the CE Mark*, the Elecsys β-Amyloid (1-42) CSF, Elecsys Phospho-Tau (181p) CSF and Elecsys(R) Total-Tau CSF immunoassays are in vitro tests for the quantitative determination of concentrations of the β-amyloid (1-42), phospholylated tau (181P) protein and total Tau protein in human cerebrospinal fluid.1-3 The markers can be used alone or in combination.1-3 The ElectroChemiLuminescence Immunoassay “ECLIA” is intended for use on Elecsys and cobas e immunoassay analyzers.1-3

*Local product availability may vary independently from CE Mark approval.

About Alzheimer’s disease

Alzheimer’s disease is a progressive, fatal disease of the brain that gradually destroys memory, thinking skills and problem solving and impairs daily functioning such as the ability to manage one’s own activities. Biological changes are believed to start decades before clinical symptoms of Alzheimer’s disease become evident. In the early stages (prodromal to mild dementia), people may have difficulty remembering things, but daily function may or may not be impaired. In the later stage of the disease, people increasingly become reliant on others for even simple day-to-day tasks. Dementia affects 44 million people worldwide with 7.7 million new cases each year, of which Alzheimer’s disease is the most common form. There is no cure for Alzheimer’s disease. Current treatments focus on alleviating symptoms and are unable to stop Alzheimer’s from progressing because they do not affect the disease’s underlying causes.


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