Analytik Jena Launches CE IvD Kits for Dementia Diagnostics

Analytik Jena AG is launching CE-IvD-Kits for neurodegenerative diseases such as Alzheimer's, Parkinson's and Creutzfeld-Jakob disease. 'According to estimates by the WHO and Alzheimer's Disease International, the number of people with dementia in our aging society is set to rise from 1.4 million currently to 3 million by 2050 in Germany alone. The care requirements are very high, and improved diagnostics could help promising therapies be implemented more quickly and in a more targeted way,' says Alexander Berka, Head of the Life Science business unit at Analytik Jena AG.

'Some neurodegenerative diseases are the result of protein aggregation, which can now be measured in a highly specific way and in different stages. To do this, we take all neurodegenerative diseases into consideration and develop diagnostic tests that enable a multi-parameter analysis. This puts us in a position to be able to differentiate more effectively between different diseases that may have similar symptomatic profiles,' explains Dr. Ingolf Lachmann, Head of Research and Development at the Analytik Jena subsidiary AJ Roboscreen GmbH in Leipzig, Germany.

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 the Leipzig facilities.

Analytik Jena AG will be launching the sale of products for Alzheimer's disease diagnostics in January with hTAU total ELISA and pTAU rel ELISA. The CE-IvD-Kits for analyzing 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 standardized 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)). 'The high specificity is down to the unique characteristics of the 5G4 antibody, which has set new standards in the diagnostics of conditions such as Parkinson's disease (Kovacs et al. 2012 and 2014),' Lachmann continued.

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)). 'The BetaPrion HUMAN EIA ELISA enables precisely this quantification of the biomarker and will turn into an essential test for distinguishing CJD from Alzheimer's disease,' Lachmann says.

Analytik Jena AG will attend the 12th International Conference on Alzheimer's and Parkinson's Diseases and Related Neurological Disorders (AD/PD™ 2015) March 18 to 22, 2015 and the Neuroscience event in Chicago from October 17 to 21, 2015, to present its innovative products of immunoassays and antibodies for use in the field of neurodegenerative disease, as well as in research and development and clinical diagnostics.