FDA has granted breakthrough device designations to the Elecsys Beta-Amyloid (1-42) CSF and Elecsys Phospho-Tau (181P) CSF assays from Roche, Basel, Switzerland.

The in vitro diagnostic immunoassays are intended for the measurement of beta-amyloid and phospho-tau concentrations in the cerebrospinal fluid (CSF) of adult patients with cognitive impairment who are being evaluated for Alzheimer’s disease or other causes of dementia. Using the new immunoassays to measure CSF biomarkers associated with Alzheimer’s disease pathology can increase the certainty of a diagnosis of Alzheimer’s disease, and help to evaluate progression of the 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 functioning may or may not be impaired. In the later stages of the disease, people become increasingly reliant on others for even simple day-to-day tasks.

Alzheimer’s disease is the most common form of dementia, which affects 44 million people worldwide, with 7.7 million new cases each year. 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.

Current diagnoses of Alzheimer’s disease are typically based on clinical symptoms, including cognitive testing. However, a diagnosis of Alzheimer’s disease based on cognitive measures alone is correct in only 70% to 80% of cases. A significant number of patients are not diagnosed until their disease has already reached an advanced stage.


Roland Diggelmann, Roche Diagnostics.

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 beta-amyloid peptides and neurofibrillary tangles in the brain are the two earliest biological changes associated with the development of Alzheimer’s disease and can be detected by several methods. CSF biomarkers can help clinicians detect Alzheimer’s disease at an earlier stage.

FDA’s breakthrough device designations are for the indications for use of the Elecsys Beta-Amyloid (1-42) CSF and Elecsys Phospho-Tau (181P) CSF assays in conjunction with amyloid positron-emission tomography (PET) visual read results and risk of cognitive or functional decline. The agency’s breakthrough devices program is a voluntary program for certain medical devices that provide for more effective diagnosis or treatment of a life-threatening or irreversibly debilitating disease or condition. The program is designed to expedite the development and review of such medical devices.

Currently available for countries accepting the CE mark, the Elecsys Beta-Amyloid (1-42) CSF, Elecsys Phospho-Tau (181p) CSF, and Elecsys Total Tau CSF immunoassays are in vitro tests for the measurement of concentrations of beta-amyloid (1-42) peptide, phospholylated tau (181P) protein, and total tau protein in human cerebrospinal fluid.1–3 The electrochemiluminescence immunoassays are intended for use on Roche’s Elecsys or Cobas e immunoassay analyzers, and can be used separately or in combination with one another.

“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 Alzheimer’s disease at an early stage,” says 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.”


  1. Elecsys Beta-Amyloid (1-42) CSF [method sheet, online]. Basel, Switzerland: Roche Diagnostics, 2018. Available at: www.cobas.com/home/product/clinical-and-immunochemistry-testing/elecsys-abeta42.html. Accessed July 20, 2018.
  1. Elecsys Phospho-Tau (181P) CSF [method sheet, online]. Basel, Switzerland: Roche Diagnostics, 2018. Available at: www.cobas.com/home/product/clinical-and-immunochemistry-testing/elecsys-ptau.html. Accessed July 20, 2018.
  1. Elecsys Total Tau CSF [method sheet, online]. Basel, Switzerland: Roche Diagnostics, 2018. Available at: www.cobas.com/home/product/clinical-and-immunochemistry-testing/elecsys-ttau.html. Accessed July 20, 2018.