CE IvD Kits for Dementia Diagnostics Launched

Analytik Jena AG have launched CE-IvD-Kits for neurodegenerative diseases such as Alzheimer's, Parkinson's and Creutzfeld-Jakob disease.

Recombinant proteins and the development and manufacture of innovative monoclonal antibodies that bind specifically to the various biomarkers in the patient form the basis for the Analytik Jena AG immunoassay products developed at their Leipzig facilities.

Analytik Jena AG launched the sale of products for Alzheimer's disease diagnostics in January with hTAU total ELISA and pTAU rel ELISA. The CE-IvD-Kits for analysing the total tau and a new form of the tau protein (pTau rel ELISA) in the cerebrospinal (CSF) fluid of patients with suspected Alzheimer's disease enable a diagnostic quality that achieves exceptional results in terms of specificity and sensitivity. The standardised kits are easy and quick to use, and are well suited to automation on the relevant platforms in routine diagnostics. Analytik Jena will also continue to provide kits for detecting human α-synuclein ( Human α-Synuclein MONO ELISA ) and its pathological aggregates ( Human α-Synuclein PATHO ELISA ). Initial clinical trials have already shown their suitability as diagnostic tests for the detection of Parkinson's disease (Unterberger et al. (2014)).

A third area of focus is on the differential diagnostics of rapid-onset Creutzfeld-Jakob disease (CJD), which is caused by prions. The identification of this disease, which is extremely serious for the patient and which shot to prominence in the bovine spongiform encephalopathy crisis, by distinguishing it from forms of dementia such as Alzheimer's disease is a major challenge in neurochemical diagnostics. A recent study showed that atypical cases of Alzheimer's disease could be clearly distinguished from CJD via the detection of prions in CSF samples (Dorey et al (2015)).