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NextGen Introduces New Generation Biomarker Products for Brain Disorder Diagnostics

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NextGen Group Plc (AIM: NGG), an AIM listed company developing its own diagnostics product pipeline and providing diagnostic biomarker development services, announces the commercialisation of a new assay for the identification of diagnostic biomarkers in brain disorders.

The assay measures protein markers in human cerebrospinal fluid.

The new assay will expand the product offering of NextGen’s contract research subsidiary, NextGen Sciences Inc.

An assay is the procedure for measuring the effects of a chemical in an organism. For example, assays are used to discover biomarkers which are used to identify the existence and progression of a disease. Biomarkers are used in clinical trials to aid in patient selection and to evaluate the effectiveness of a drug. They are also used in the development of companion diagnostics that will drive the growth of the personalised medicine market.

There is a significant need for biomarkers to monitor and diagnose central nervous system disorders, such as dementia, Parkinson’s disease and neuropsychological disorders, within the patient care and drug development industries.

The “CSFassay-human B.1.0” product is capable of measuring 173 cerebrospinal fluid (CSF) proteins simultaneously that have been identified as likely biomarkers in various central nervous system (CNS) disorders.

Barry McAleer, PhD, CEO of NextGen Sciences Inc says: “This new product and those currently in development are already attracting interest in the marketplace and we are in discussions with a number of clients who wish to use these assays in their R&D programmes.”

The release of the CSFassay-human B.1.0 product is the second assay in the family of human CSF assays and will be followed shortly by the first generation of animal species assays from NextGen.

The extension of the assays to animal species means that they can be used in early stage clinical and pre-clinical trials where treatments may be tested on subjects such as rats.

Explains Barry McAleer: “We can now apply our technology to make custom assays for our customers in human CSF and plasma, in multiple species and for hundreds of proteins. We can do it in just a few months.”

“Make no mistake, what we are developing here is the tip of the assay iceberg. The quality of the assays and the numbers of proteins which in a short timeframe we will be able to assay is going open up massive potential to our NextGen’s diagnostics subsidiary in its own research programmes for the discovery of diagnostic markers in CNS disorders.”

NextGen uses mass spectrometry (a technique for specifically identifying and quantifying biomarkers in samples) as its core technology to discover highly specific protein biomarkers that can be used for diagnostic purposes.

In 2010, the total global market for biomarkers was an estimated $13.5 billion and is expected to grow to nearly $33.3 billion by the end of 2015 (BCC Research).

Adds Barry McAleer: “This assay is a variation on how we have used our technology to date and it has enabled the product to be developed in 1-month. Really, we did this work as proof-of-concept but now we are ready to expand our products rapidly and on three fronts. Firstly we will develop further assays in humans that will allow us to measure many more hundreds of proteins in CSF. Secondly we will apply these principles to expand the protein numbers we can measure in human plasma. Thirdly, we will introduce assays for the same proteins in rat and monkey species.”

“What we now know is that we can offer assays to our customers that will enable them to find biomarkers in different animal species models and that can be applied at different stages of drug development, both pre-clinical and clinical. When they find the key protein biomarkers we can place them all into a single, cross-species assay.”

“The speed with which we can develop these assays (three times faster than our previous assays), in multiple species and with hundreds of analytes, signifies a huge step forward in the speed with which we can look to grow our business. We go from strength to strength in our drive to be a leader in providing high quality assays for many proteins for which until now there were no assays.”

Klaus Rosenau, Chairman of NextGen Group PLC, explains: “The rapid progress we continue to make in our technical capabilities and in the release of new products is opening up a very significant set of new resources to customers who are focused on using biomarkers to drive sustainable drug development programmes.”

“We intend to rapidly exploit our current and near future products within the project engine pipeline of the NextGen Sciences Dx business. We have several projects within our diagnostics project engine that are at different stages in progress as we seek to generate further intellectual property and seek out biomarker sale/licencing/testing routes to build value for our shareholders.”

In 2010, the total global market for biomarkers was an estimated $13.5 billion and is expected to grow to nearly $33.3 billion by the end of 2015 (BCC Research).

Source: NextGen Sciences