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Mar 1, 2010 (Vol. 30, No. 5)

Development Strategies for Biomarker Assays

Approaches for Overcoming Obstacles to Successful Implementation in the Clinic

  • Choosing the Right Platform

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    Icon Development Solutions has a large range of technological platforms, which it says are necessary in order to provide its customers with the most appropriate analytical solutions.

    Biomarker discovery platforms fall into two main categories: pure research and clinical diagnostics. Because of a natural division between manufacturers of instruments for these two types of applications, even people who have worked with biomarkers extensively have generally not used both research and clinical platforms. These two groups of instruments have evolved over time in design and functionality.

    However, early-stage biomarker research and clinical biomarker development are uniquely interrelated activities. There is a need for service providers to embrace both sets of technology and access a repertoire of platforms along the entire chain of biomarker development.

    “There is no one platform that fits all,” said John Allinson, vp, biomarker laboratory services of Icon Development Solutions. “You need a large range of platforms to be able to give the most appropriate analytical solution to whatever the challenges are in the drug development programs you’re working with.”

    Allinson particularly warns against clinically uninformed biomarker investigations. Attempting to characterize biomarkers without a grounding in physiology—such as not understanding the normal physiological range of certain protein markers—can lead to some disastrous mistakes.

    “I’ve known some laboratories that have produced biomarker results data that is incompatible with living systems. It’s purely because they don’t have a thorough understanding of the clinical side of the science.”

    It can be challenging to take a set of biomarkers identified during a discovery phase and validate them to acceptable clinical standards. To address this task, Rules Based Medicine (RBM) decided to take a multianalyte profile (MAP) approach. The company developed DiscoveryMAP™ technology, based on the Luminex platform, and has come up with a multianalyte profile for schizophrenia. The profile includes 51 biomarkers that provide a pattern to differentiate a healthy state from schizophrenia with diagnostically relevant sensitivity and specificity, explained Ralph L. McDade, Ph.D., strategic development officer at RBM.

    The profile also contains biomarker signals that the company believes will help psychiatrists to differentiate schizophrenia from bipolar disorder and major depression. Several of the analytes are treatment-sensitive, and RBM is working with Roche  to develop these and others as theranostic candidates.

    Although the concept of capturing profiles and patterns for diagnosis of disease is intuitively appealing, the successful execution of a profile-based biomarker is complicated by the precision and reproducibility of results. Matrix interference has been one of the greatest challenges for RBM, which they sought to overcome by developing various cocktails of blocking solutions.

    “That probably was the most complicated aspect of getting DiscoveryMAP to reliably validate in a clinical setting. Nobody had ever done that in a multiplexed environment and to my knowledge no one has since,” says Dr. McDade. “Without that you can’t have the precision that is required in the clinical laboratory.”

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