March 1, 2006 (Vol. 26, No. 5)

Changes Designed to Hasten Technology Flow into the Clinical Diagnostics Marketplace

Beckman Coulter ( has just completed a restructuring that is pulling down the divisional walls between biomedical research and clinical diagnostics, says Jeff Chapman, business manager, proteomics. The changes are expected to create an environment where new technologies will move more rapidly from research and discovery through translational testing (where technology first meets patients), and ultimately into clinical diagnostics.

The restructuring is not a dramatic change, but rather a subtle one aimed at removing the barriers between divisions at Beckman Coulter. The reorganization allows ProteomeLab, GenomeLab, and CellLab products to advance the diagnosis of disease, states Christopher Neary, vp, biomarker discovery and lab automation at Beckman Coulter, headquartered in Fullerton, CA. The changes will produce more streamlined methodologies geared toward speeding the flow of technology into the clinical marketplace, he says, adding that the company remains focused on providing complete solutions for key customer applications.

Automating Molecular Diagnostics

Neary cites the new Vidiera NsD Nucleic Sample Detection Platform as an example of how the company is advancing technology from research to diagnostics. It is a fully automated platform for molecular diagnostic laboratories that separates DNA molecules by capillary electrophoresis. The system can run two 96-well plates, and batches of eight samples can be processed in as little as 30 minutes. Another new product, the Vidiera NsP Nucleic Sample Preparation System, is a fully automated platform that performs nucleic acid isolation, quantitation and normalization, and reaction setup.

Vidiera NsD and NsP utilize Beckman Coulters expertise in capillary electrophoresis and lab automation for molecular diagnostic applications. They can assist laboratories in developing assays for hematopathology, oncology, cardiovascular health, and inherited disorders. In response to customer demands, we brought our experience in clinical diagnostics and research genetics together to develop these products for the growing field of molecular diagnostics, says Dwight Denham, business manager, molecular diagnostics.

Hospital labs are incorporating the Vidiera products to reduce bottlenecks in work flow and speed turnaround time on patient results. Beckman Coulter is developing more reagents for these platforms that can be incorporated into existing and new laboratory tests. New molecular testing platforms are on the horizon to isolate markers for conditions such as cancer, cardiovascular disease, and diabetes.

IgY Speeds Proteome Enrichment

A new family of ProteomeLab Partitioning Systems and Chemistries assists in the discovery of new biomarkers. The IgY platform enriches low abundant proteins within serum, plasma, and cerebral spinal fluid samples, says Chapman. ProteomeLab IgY-12 Proteome Partitioning Chemistry is the first product in this new line for the isolation and analysis of protein-based biomarkers from serum or plasma.

The IgY chemistry partitions proteins using avian-generated antibodies bound to inert beads. The resulting enriched proteome is the primary target for biomarker discovery. The material can be further fractionated on the ProteomeLab PF-2D System.

Sample enrichment and fractionation is the Achilles heel of any biomarker discovery program, where the goal is to identify change in a milieu of complexity, says Chapman. The 12 proteins specifically partitioned by the IgY chemistry account for up to 96% of the protein mass in serum or plasma. In contrast, alternative plasma depletion methods remove no more than six proteins.

Highly abundant proteins significantly mask potential biomarkers. Digging deeper into the proteome enhances the discovery and validation of biomarkers and drug targets, Chapman adds. The IgY Proteome Partitioning Chemistry products come as a complete solution, including liquid chromatography and spin columns, validated methodology, reagents, and instrumentation.

New Genomic Tools

Several new genomic tools also extend the complete solutions concept. GenomeLab GeXP Genetic Analysis System provides high-throughput, quantitative gene expression analysis with scalable, multiplexed PCR. GenomeLab GeXP allows multiplexing of up to 30 genes in one well for quantitative gene expression.

The new technology fits in between microarrays and real-time PCR, says Noreen Galvin, GenomeLab business manager. Even though microarrays can analyze thousands of genes simultaneously, real-time PCR, a time-consuming process, is needed for confirmation. We filled a need to bridge those two technologies, says Galvin. The new system runs two 96-well plates in 24 hours and operates at a fraction of the cost of standard real-time PCR.

Beckman Coulter also recently introduced the 48-plex GenomeLab SNPstream Genotyping System, an automated, microarray-based system that processes up to 48 SNPs in each well of an arrayed 384-well plate. The 48-plex SNPstream System features a three-step protocol, compared to up to 15 steps in competing systems.

Researchers are looking at smaller numbers of SNPs in signature panelsanywhere from 10 to 100 SNPs, says Galvin. We envisioned the sweet spot is about halfway between, or about 48 SNPs.

The recent acquisition of Agencourt Bioscience advances Beckman Coulters offerings in genomic services and nucleic acid purification. Agencourts Solid Phase Reversible Immobilization (SPRI) technology was used to prepare one-third of the sequences analyzed by the Human Genome Project. The sample preparation tools add new chemistries to the Biomek automated liquid-handling platforms.

Tools for Cellular Analysis

Beckman Coulters flow cytometry systems and reagent offerings also serve both research and diagnostic markets. The companys successful FC 500 platform serves the research market while also addressing the clinical market with in vitro applications, such as tetraCXP for CD4 monitoring and stemCXP for stem cell monitoring, along with flexibility to meet researchers needs. The new Cell Lab Quanta and Quanta SC (with side scatter measurement) offer alternative flow cytometry solutions for research outside of core labs.

Beckman Coulter is expanding its line of cellular research reagents to include monoclonals based on both human and animal models and bead-based multiplex reagents with key human mouse multiplex cytokine panels.

In other recent developments, Affymetrix ( awarded its Premier Application Status to Beckman Coulters ArrayPlex for automated target RNA preparation in September. The ArrayPlex, based on the Biomek FX liquid handling platform, allows researchers to automate sample preparation for the Affymetrix GeneChip. This technology will accelerate R&D and marketing of new tests and therapies.

The Premier Application Status permits Beckman Coulter to market its ArrayPlex technology to Affymetrix customers. At the recent Lab Automation Conference in Palm Springs, the company introduced the Biomek 3000 ArrayPlex, which Beckman Coulter describes as a more economical, lower throughput option.

Some mature lab workhorses like Beckman Coulter centrifuges have also been improved. They now come with enhanced biosafety features for containing biological hazards, such as transparent Aerosolve canisters and biocertified covers to prevent aerosol contamination. Centrifugation is a fundamental tool used in all processes, including genetic analysis, cellular analysis, and biomarker discovery. It all starts with spinning down that cell lysate, removing the debris, and precipitating the protein, says Chapman.

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