NextGen Group Plc has announced the commercialization of a new assay for the identification of diagnostic biomarkers in brain disorders in animal models.
The assay measures protein markers in rat cerebrospinal fluid and 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 in turn 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 personalized 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.
NextGen’s “CSFassay-rat A.1.0” product is capable of measuring 62 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: “Assays that can discover biomarkers in animal models will enhance the drug development process within the pharmaceutical industry and could lead to reduced attrition in the drug development process. With the introduction of the CSFassay-rat A.1.0 we have delivered on the first phase of ongoing product development plans that enables us to support and enhance the pre-clinical drug development programs of our customers. 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-rat A.1.0 product is the first assay in a family of animal model CSF assays and provides confirmation of NextGen’s previously stated intention to deliver assays in animal species.
Explains Barry McAleer: “Our customers can choose to employ our current assay products in their diagnostic biomarker programs or they can ask us to make custom assays for them, in multiple species, in CSF and plasma and for hundreds of proteins. We can do it in just a matter of weeks.
“With our previously released human CSF and plasma assays we continue to widen the landscape for our customers to find diagnostic biomarkers in different animal species models. These biomarkers can be combined in a single assay that can be employed through the pre-clinical and clinical stages of drug development. This improves the chances for diagnostic markers to proceed all the way through to companion diagnostics and to aid the personalization of medicine.”
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.
“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.”
Klaus Rosenau, Chairman of NextGen Group PLC, explains: “We continue to strengthen our position towards becoming be a leader in providing high quality diagnostic biomarker assays. We intend to increase the speed with which we can exploit our technology and products within the project engine pipeline of the NextGen Sciences Dx business. Projects are already at different stages of development as we pursue our ambition to generate further intellectual property and seek out biomarker sale/licencing/testing routes to build shareholder value.”
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).