TRF

Thursday 22nd July, 2010

Development opens potential for earlier detection and treatment of major diseases

New immunoassay platform co-developed by Cambridge Consultants and XenBio Fluidics, based on time-resolved florescence (TRF) label helps enable low-cost, near patient diagnostics tests

Cambridge Consultants has today announced the development of a new platform that enables a range of rapid diagnostic tests (RDTs), previously only achievable in a clinical environment, to be performed in a near patient setting. The new immunoassay platform is based on a novel time-resolved florescence (TRF) label and low-cost portable detection technology, providing the precision, accuracy and sub-pM sensitivity expected of a clinical laboratory in a cost effective near-patient setting, better enabling earlier diagnosis and the detection of a wider range of biomarkers.

As the demand for point of care (POC) and over-the-counter (OTC) rapid testing increases, the opportunity to introduce new assays to the mass market is growing. Lateral flow immunoassays are a well-established technology and the use of gold labels is commonplace. As the market begins to saturate, RDT manufacturers are looking to the next generation of POC and OTC tests, which must offer higher sensitivity in order to satisfy the demand for earlier diagnosis and the detection of a wider range of biomarkers.

"The advent of low cost digital readers means that the sensitivity of gold-based tests is reaching its limit," explains Simon Burnell, Head of Diagnostics at Cambridge Consultants. "Recognising the need for innovation, we have developed a platform that will enable our clients to take lateral flow immunoassays to the next level, developing the next generation of high sensitivity tests at a low cost point previously impossible."

Cambridge Consultants' platform is based on the combination of a TRF reader and label that achieve high sensitivity by using a temporal, rather than spectral separation of excitation and detection light. At the core of the new platform is an innovative TRF label that offers far greater levels of sensitivity compared to existing gold labels. The new label, when integrated with Cambridge Consultants' sophisticated detection unit, can deliver over four orders of magnitude improved sensitivity compared to gold labels. Using an NT-proBNP assay, Cambridge Consultants has demonstrated that the new platform is capable of detecting the biomarker in concentrations of less than 1pM and under certain conditions as low as 0.01pM.

Cambridge Consultants and XenBio's new platform can be applied to a number of substrates, arrays and planar surfaces as well as being capable of being retrofitted to a range of existing lateral flow assays. As a result new tests can quickly be brought to market. Simon Burnell continues, "With our medical device development process, we can offer a programme which would take a TRF based diagnostic test to prototype within 3 months, and to market within a year. We also offer the opportunity to licence our proprietary reader technology in this field."

Cambridge Consultants will also be demonstrating the new platform at the 2010 AACC Annual Meeting andClinical Lab Expo in Anaheim, USA, July 27-29.

Notes to editors

Cambridge Consultants develops breakthrough products, creates and licenses intellectual property, and provides business consultancy in technology critical issues for clients worldwide. For more than 50 years, the company has been helping its clients turn business opportunities into commercial successes, whether they are launching first-to-market products, entering new markets or expanding existing markets through the introduction of new technologies. With a team of more than 380 staff, including engineers, scientists, mathematicians and designers, in offices in Cambridge (UK), Boston (USA) and Singapore, Cambridge Consultants offers solutions across a diverse range of industries including medical technology, industrial and consumer products, transport, energy, cleantech and wireless communications.

Cambridge Consultants is part of Altran, a global leader in innovation and high-tech engineering consulting which supports companies in the creation and development of their new products and services. With a staff of 20,000 employees in more than 20 countries, the Group generated revenues of €1,456m in 2012. For more information visit: www.altran.com

About XenBio

Xen Biosciences, Inc (XenBio) is an early stage biotechnology company located at the heart of San Diego’s Golden Research Triangle. It was founded in 2005 to develop and commercialize novel in vitro diagnostic (IVD) technologies to allow accurate answers to health questions at the doctor’s office, home, mall, and other point-of-use locations. XenBio’s proven and patented portable detection platform is poised to address the need for real time, low cost, point-of-use solutions for the heart disease and breast cancer diagnostics markets. XenBio presently offers development services on behalf of clients with access to other validated markers.

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