Landmark “iStopMM” Trial to Start

13 Apr 2016
Alex Waite
Editorial Assistant

Industry news

Binding Site is proud to be a key collaborator with Prof Sigurdur Kristinsson of the University of Iceland in his pivotal MGUS screening study for the forthcoming iStopMM (Iceland Screens, Treats or Prevents Multiple Myeloma) trial.

The study will examine blood samples from approximately 140,000 adults over age 40 in Iceland for the earliest signs of myeloma. A cancer of the blood plasma cells that affects approximately 90,000 in the US, and more than 200,000 around the world, myeloma can go undiagnosed until the disease begins to seriously damage health.

The company has been a significant contributor to the study design, is crucial to its execution, and will lead the initial screening phase of the study from their state of the art facility in Birmingham, UK. They will be utilising the Freelite® immunoassays together with automated electrophoresis testing equipment.

Dr Stephen Harding, R&D Director, and one of the instigators of this study said “iStopMM is at the heart of everything Binding Site has stood for since the launch of Freelite®; we are delighted to support Prof Kristinsson and to continue our close collaborations with both he and Prof Ola Landgren from Memorial Sloane Kettering”

Freelite® is a unique polyclonal antibody-based test, specifically designed by Binding Site to accurately and precisely measure monoclonal free light chains in blood. Free light chains are produced in a variety of haematological (blood) cancers including Multiple Myeloma. The introduction of the Freelite® test into clinical laboratories in 2001 changed the paradigm for patients – its use has made a major contribution to a better understanding of these disease conditions and their outcome. Freelite® is the only test approved by the International Myeloma Working Group for quantifying serum free light chain.

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ElectrophoresisElectrophoresis equipment is used to separate mixtures of protein, DNA or RNA, based on their electric charge, size and other physical characteristics, by passing them through a medium such as a polyacrylamide gel, an agarose gel or a capillary tube. Electrophoresis equipment includes horizontal and vertical gel electrophoresis chambers, isoelectric focusing systems, 2D electrophoresis and capillary electrophoresis instruments. Precast gels with a gradient can be used or gels can be hand cast. Samples are run alongside ladders or markers to identify the approximate size of a molecule. Separated proteins and nucleic acids in the gel can be stained or probed with fluorescent markers and then imaged and detected using gel documentation instruments, transilluminators, densitometers and scanners. Find the best electrophoresis equipment in our peer-reviewed product directory: compare products, check customer reviews and receive pricing direct from manufacturers.AntibodiesAntibodies are used in techniques such as confocal and fluorescence microscopy, flow cytometry, ELISA, ELISPOT, immunohistochemistry, western blotting and immunopreciptation. Select specific antigen reactivity, high specific affinity, low non-specific binding, monoclonal or polyclonal, primary or secondary antibodies and associated conjugates such as an enzyme or dye for visualization.Data AnalysisData analysis hardware and software is available to make data processing straight-forward yet powerful. Data software can be used for math and stats, technical graphing and image analysis. In addition, software is available for specific data analysis of electrophoresis, densitometry, ELISA and DNA sequencing.Sample ManagementSample management systems include sample storage devices such as freezers and plate storers, sample environment enclosures and sample organization, retrieval and sorter systems. Useful system features include high-throughput, automation, robotic arms, automated liquid handling and associated database systems. Accessories in sample management include barcode scanners, heat sealers and tubes.Microarray AnalysisMicroarrays, also known as biochips, are used for the detection and analysis of multiple genes, proteins, antibodies, or biomarkers on a single microchip. This can reveal information on protein or gene expression, single nucleotide polymorphism (SNP), copy number variation (CNV), epigenetics and patient health in clinical diagnostic tests. Discover a range of microarray scanners and prefabricated antibody, protein, RNA and DNA microarrays for your analysis or consider creating your own custom microarrays with a microarray printer. Find the best microarray products in our peer-reviewed product directory: compare products, check customer reviews and receive pricing direct from manufacturers.ImmunologyImmunological techniques measure and characterize immune responses. Immunology kits and analysis systems often use techniques such as ELISA, radioimmunoassay (RIA) and immunodiffusion assays, Immunohistochemistry, and flow cytometry. Immunologists use equipment such as flow Cytometers, plate readers, plate washers and fluorescent microscopes.Cellular PathologyCellular Pathology deals with the microscopic analysis of tissue samples and cells. Sample preparation and processing includes fixation, staining, sectioning and slide mounting, using equipment such microtomes and cryostats. In choosing immunohistochemistry and immunocytochemistry kits, consider chromogens, staining method, antibodies, microscopes and imaging.Cell-Based AssaysCell-based assays are used to monitor the presence, quantity and activities of a desired cellular analyte including drug molecules or biomarkers. This can reveal information on cell health (apoptosis, cytotoxicity, viability and proliferation assays), cell metabolism, cell migration and cell signaling mechanisms. Find the best cell-based assay products, kits and equipment with our peer reviewed product directory: compare products, check customer reviews and receiving pricing direct from manufacturers.Clinical TrialsClinical Trials, an essential part of drug discovery process, assess the safety and effectiveness of a new medication or device in the pharmaceutical industry. Clinical Trials are a phased process (Phase 0, Phase I, Phase II, Phase III and Phase IV) which begins after initial preclinical testing.Robotic InstrumentsRobotic instruments can be used for high-throughput automation of many lab processes. Such processes use instruments for assays like cell based assays and ELISA, for sample preparation like shakers, centrifuges and incubators, and for analysis such as sequencing and western blot analyzers. Useful features of robotic instruments include speed, reproducibility, barcode readers, software and automation.Robotic WorkstationsRobotic workstations are automated platforms enabling the user to perform high-throughput, multi-application processes, from sample preparation tasks such as PCR set-up, DNA purification and NGS library preparation, to integrated sample prep and analysis workstations. Automation makes processes consistent, fast, precise and fully walk-away. Find the best robotic workstations in our peer-reviewed product directory: compare products, check customer reviews and receive pricing direct from manufacturers.RegulatoryPharmaceutical regulations impact on all areas of drug development, manufacture and control and supply. Services are provided from the early stages of drug development and clinical trials through to dossier submission, approval and marketing. Regulatory also includes submission of analytical studies from the pharmaceutical product and safety. ImmunoassayImmunoassays are laboratory tests that utilize antibody-antigen interactions to detect specific substances. They are widely used in diagnostics for detecting diseases, drug testing, and environmental monitoring. These assays offer rapid, sensitive, and precise detection of biomarkers, making them invaluable in clinical and research labs. Browse our peer-reviewed product directory to compare immunoassay systems, read user reviews, and get pricing directly from manufacturers.Monoclonal AntibodiesMonoclonal antibodies (mAbs) are lab-made molecules that can bind to specific antigens on cells, making them highly effective in treating cancers, autoimmune diseases, and infections. These targeted therapies are transforming the treatment landscape for many conditions. Browse our peer-reviewed product directory to find monoclonal antibodies for research and clinical applications; compare products, check reviews, and get pricing directly from manufacturers.Clinical AutomationClinical laboratory automation refers to the use of automated systems in clinical laboratories to increase efficiency, reduce human error, and improve patient care. From sample analysis to total laboratory automation, this plays a critical role in modern diagnostics and laboratory workflows. 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Landmark “iStopMM” Trial to Start