Pre-analytical Variability and OBBR

Biomarker analysis is only as good as the quality of the biospecimen on which it is based. Living tissue biospecimens begin to degrade the moment they are removed from the body, altering the biomarker signal. This degradation of the biomarker signal, before the sample is analyzed, is known as pre-analytical variability. This variability may profoundly change the molecular composition or profile of the biospecimen within short periods of time. Although these represent artificial changes, they risk being misinterpreted as disease-related or even disease-specific. Thus, to gain the most out of biomarker analysis and to avoid misinformation, pre-analytical variability must be minimized.

Biospecimen quality and variability have been repeatedly identified by the scientific community as a leading obstacle to progress in cancer research. The NCI is committed to resolving this complex problem through a multifaceted approach that addresses those factors under our control and provides insights that will inform broader policy making in this area.

The mission of the Office of Biorepositories and Biospecimen Research, part of the NCI, is to “ensure that human specimens available for cancer research are of the highest quality.” In early 2006, the OBBR initiated the Biospecimen Research Network (BRN) to systematically address the impact of specific variables in individual specimen types on molecular data from given analysis platforms. The goal of the BRN is to address these issues by sponsoring, conducting, and collaborating on studies to assess the effects of human specimen pre-analytical variables on the outcome of genomic and proteomic studies conducted for clinical diagnosis and cancer research purposes.

Based on this vision, the BRN has been designed to address the following challenges:

  • Bridging the gap between existing clinical practice for biospecimens and emerging technologies for personalized diagnostics and therapies;
  • Defining the most significant variables for prospective collection of tissues, blood, and bodily fluids;
  • Developing evidence-based biospecimen quality indicators for specific analytical platforms.
    • The activities of the BRN program include a public outreach effort to define issues around human specimen research, and identify the most pressing needs for human analyte standardization. Activities include an annual meeting, the BRN Symposium.

Additional information about the Biospecimen Research Network can be found here: BRN Fact Sheet PDF, Document: 2.69 MB

Source: Helen M. Moore, Ph.D.
Office of Biorepositories and Biospecimen Research National Cancer Institute, NIH
View complete presentation from the 2012 BRN Symposium.