Improve Alzheimer’s Diagnosis: Roche’s Two Elecsys® Cerebrospinal fluid Diagnostic Kit Obtained FDA “Breakthrough Equipment” Qualification

  • 2018-07-20

Roche announced recently that the US Food and Drug Administration (FDA) has grantedElecsys® ß-Amyloid (1-42) CSF and Elecsys® Phospho-Tau (181P) CSF Breakthrough Equipment Qualification (BDD). The two in vitro immunoassay kits are for the detection of beta-amyloid (1-42) in cerebrospinal fluid (CSF) and the level of Phospho-Tau protein in adults with Alzheimer’s disease (AD) or dementia of other causes and cognitive impairment.

Roland Diggelmann, CEO of Roche Diagnostics, said that we are very happy the FDA’s grant of BDD is a sign of the agency’s recognition that the Elecsys CSF assay can provide potential clinical benefits for clinicians and their patients in the early stages of diagnosis. Roche is one of the first companies to use biomarkers in clinical trials, and we will continue to explore high-performance diagnosis and disease surveillance solutions.

Determining the presence of degenerative diseases in the central nervous system is important in distinguishing age-related memory impairment from early dementia. The deposition of β-amyloid peptide (1-42) and neurofibrillary tangles in the brain is the earliest two changes in AD and can be detected by different methods. Biomarkers in CSF can help clinicians detect AD which is the most common type of dementia at an early stage. Elecsys β-Amyloid (1-42) CSF, Elecsys Phospho-Tau (181p) CSF, Elecsys(R) Total-Tau CSF Immunoassay Kits are commercially available in countries that receive the CE marking, and can be used to determine the concentration of β-amyloid peptide (1-42) in human CSF, phospho-tau protein (181P), total tau protein. These markers can be used singly or in combination.