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April 01, 2008 (Vol. 28, No. 7)

Biobanks Can Make or Break Biomarkers

Quality Conformance Comes Into Play on Both the Front and Back End of Research Programs

  • Previously, the NCI raised an alarm about the wide range of biospecimen quality used for research programs seeking novel biomarkers for diseases and the resulting tests that aid in the diagnosis of those diseases. During the NCI “Biospecimen Best Practices Forum” held in Seatle in January the warning was repeated.

    The NCI identified the absence of standardized, high-quality biospecimens as a major issue in the progress of cancer research. Last year, the institution updated its first-generation guidelines for biorepositories with the publication of “Best Practices for Biospecimen Resources.” The document defines state-of-the-science biospecimen resource practices.

    The call for standardization in any industry necessarily follows in the wake of fast-breaking adoption of technology that pushes the boundaries of existing standards or simply passes them by in a rush to market. Pharmaceutical and biotechnology companies are rushing headlong toward a ready market for personalized medicine by pushing accelerated data processing as well as today’s high-throughput processing for biological specimens. The pressure is on research teams to rapidly identify blockbusters for disease diagnosis among a myriad of metabolites, proteins, and genes.

    Key Criteria for Selection

    Where selecting a biorepository would seem to be limited to selecting a resource provider, experience from biomarker-discovery programs shows a biobank provider becomes an essential partner in project development and plays a critical role in the speed of development and discovery. Ultimately, it is inextricably linked to the quality of the findings. It is not an exaggeration to say a good biorepository can accelerate research by several years and an unfortunate choice can have the opposite effect.

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    On the front end, a biorepository needs to be capable of providing valid specimens with informed consent firmly attached. Next, the biobank should hold a depth of clinical and demographic data on each specimen to verify initial discoveries and support validation. Finally, the bioresource should be able to offer a selection of same-patient tissues for cross-reference research to validate findings. In the case of blood-based collections, the availability of tightly matched healthy control samples is essential.

  • Ethical collection, specimen integrity, and data quality are three categories of investigation when looking at candidate biobanks. Evaluation should be conducted well ahead of launching research activities.

    Ethical collection is often summarized in three letters: IRB (Institutional Review Board). Impaneled to protect the rights and welfare of human subjects, IRB review is federally mandated for research on humans. So, while that upstream conformance to IRB protocols by a biorepository would seem a given, it should be challenged and verified. To put it another way, failure to assure proper patient-informed consent for specimen research opens the door to claims against eventual intellectual property.

    The collection, handling, and storage of all biological specimens with integrity relies on known science that can be verified. Most reliable will be the provision of genetic samples that are essentially fixed and subject to fewer variables than the tissues and sera needed for proteomic and metabolomic experimentation. Proteins and metabolites can be ephemeral and rely on uniformity in procedures on the part of the biorepository, which can be verified to a high degree of confidence.

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