Bruker Announces AVANCE™-IVDr as a Standardized NMR Platform for Clinical Screening and In Vitro Diagnostics (IVD) Discovery and Validation

Bruker today announces a standardized nuclear magnetic resonance (NMR) spectroscopy platform for its clinical and diagnostics partners that enables cost-effective, high-performance NMR clinical screening and IVD-by-NMR discovery, development and validation of novel NMR assays.

The new AVANCE-IVDr system, presently for research use only, is a complete, proven and standardized platform for NMR clinical research and screening, as well as for IVD-by-NMR research. It features high sensitivity and information-rich output at 600 MHz proton-NMR frequency, and incorporates advanced hardware, software, automation, spectral libraries and standard operating procedures (SOPs) for high-performance bio-fluid screening and assay validation. Customer benefits include higher information content and spectral feature differentiation compared to low-field NMR systems, as well as excellent reproducibility, high throughput and potentially dramatically lower cost per sample for better clinical screening and IVD-by-NMR.

Dedicated to NMR-based clinical screening and diagnostics, the AVANCE-IVDr is optimized for ease-of-use and highest data quality and reliability. The new standardized platform offers barcode analysis, control by a LIMS system, the high-throughput, temperature-controlled autosampler SampleJet™, remote access, and automatic analysis and customizable analytical results reporting. Based on Bruker-validated SOPs, the AVANCE-IVDr platform enables the development of diagnostic tools for body-fluids, or even biopsy samples that can address a variety of medical questions. The SOPs guarantee the production of highly reproducible clinical data, enabling the exchange and validation of novel NMR assays between laboratories on a global basis. In a translational clinical research environment the results produced by these NMR assays can easily be transferred into clinical screening and future IVD use.

Bruker’s NMR spectroscopy systems are already in use in more than forty clinical research centers worldwide, including hospitals working on modern health-related screening techniques, such as human metabonomics. The AVANCE-IVDr system in its latest, standardized configuration has been installed already at several customer and strategic partner sites. Cross calibrations performed by Bruker across several centers have demonstrated NMR’s unique advantage that spectra from samples prepared and measured under the Bruker SOPs are identical, independent of a center`s location or operating staff.

As a result of a long-standing collaboration with Imperial College London, the AVANCE-IVDr platform is already enabling the analysis of over 100,000 samples per year at the UK’s recently opened MRC-NIHR Phenome Centre. This level of large-scale health-related NMR screening is paving the way for worldwide epidemiological studies as well as for clinical research and diagnosis. The benefits have been significant: facilitated by the low cost per sample and the even lower cost per parameter as compared to established single parameter screening methods, novel NMR methods for determining the cause of disease, delivering individualized patient treatment and developing strategies for prevention are now available to many clinical researchers.

Professor Jeremy Nicholson, Director of the MRC-NIHR Phenome Centre and Head of the Department of Surgery and Cancer at Imperial College London, commented: “The latest generation of Bruker NMR instruments gives us staggering day to day and long term reproducibility and reliability of spectral acquisition, coupled with the ability to do automated digital quantification of multiple metabolites. Thus, uniquely, the NMR technology platform can be used in simultaneous exploratory and targeted modes. We are totally committed to the use of NMR spectroscopy (in association with mass spectrometry) as a definitive bio-screening tool, and the latest technology developments now allow the deployment of the platform on an industrial scale.”

Dr. Manfred Spraul, Bruker’s Director of Applied NMR Business Development, added: “Migrating from translational research to clinical diagnostics requires robust, identical instrumentation in research facilities and hospitals, which is why Bruker has decided to offer the standardized AVANCE-IVDr platform, enabling a smooth transfer from health research and large epidemiological studies, to our partners’ emerging IVD assays at the highest quality and reproducibility. With modern NMR technology and the right SOPs, we and our collaborators have opened the path to complex mixture analysis using push-button technology, establishing NMR as one of the two major technologies used in metabolic profiling and screening.”